Specifications.(a) (1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution).
(2) Each gram of powder contains 200 mg amprolium (20 percent).
Sponsors.(b) See sponsors in 510.600(c) of this chapter.
(1) Nos. 016592 and 061133 for use of products described in paragraph (a) of this section as in paragraph (d) of this section.
(2) No. 066104 for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section.
(3) No. 051072 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section.
Related tolerances.(c) See § 556.50 of this chapter.
Conditions of useGrowing chickens, turkeys, and laying hens.(d) —(1) It is used in drinking water as follows:
Amount.(i) Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.
Indications for use.(ii) For the treatment of coccidiosis.
Limitations.(iii) Use as the sole source of amprolium.
Calves.(2) Administer…
Specifications.(a) (1) Each tablet contains 12.5 or 50 milligrams (mg) furosemide.
(2) Each bolus contains 2 grams (g) furosemide.
(3) Each packet of powder contains 2 g furosemide.
(4) Each milliliter of syrup contains 10 mg furosemide.
Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter for use of dosage forms and strengths listed in paragraph (a) of this section for uses as in paragraph (d) of this section.
(1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section.
(2) No. 000061 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and powder in paragraph (a)(3) of this section for conditions of use in paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A).
(3) Nos. 058829 and 069043 for use of syrup in paragraph (a)(4) of this section for conditions of use in paragraph (d)(2)(i) and (d)(2)(ii)(A) of this section.
Special considerations.(c)…
Specifications.(a) Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin.
Sponsor.(b) See Nos. 000061 and 054925 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.300 of this chapter.
Conditions of useAmount.(d) —(1) Colibacillosis: 1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligram/pound/day.
Indications for use.E. coliTreponema hyodysenteriae.(2) In weanling swine for control and treatment of colibacillosis caused by strains of sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with
Limitations.(3) Do not slaughter treated swine for food for at least 3 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006; 81 FR 94989, Dec. 27, 2016]
Specifications.(a) Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin.
Sponsor.(b) See Nos. 000061 and 016592 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.300 of this chapter.
Conditions of useAmount.(d) —(1) Administer 1.15 milliliters of pig pump oral solution (5 milligrams of gentamicin) orally per pig one time.
Indications for use.E. coli(2) In neonatal swine 1 to 3 days of age for control and treatment of colibacillosis caused by strains of sensitive to gentamicin.
Limitations.(3) For use in neonatal swine only. Do not slaughter treated swine for food for at least 14 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[49 FR 572, Jan. 5, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; 78 FR 17596, Mar. 22, 2013; 81 FR 22523, Apr. 18, 2016; 88 FR 27698, May 3, 2023]
Specifications.(a) Each gram of powder contains gentamicin sulfate equivalent to:
(1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin.
(2) 333.3 mg gentamicin.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section as follows:
(1) No. 000061 for products described in paragraph (a)(1) of this section.
(2) Nos. 016592 and 061133 for product described in paragraph (a)(2) of this section.
Related tolerances.(c) See § 556.300 of this chapter.
Conditions of use in swineAmount.(d) —(1) Administer in drinking water for 3 consecutive days as follows:
(i) For colibacillosis: Gentamicin sulfate equivalent to 25 mg of gentamicin per gallon of drinking water to provide 0.5 mg per pound of body weight per day;
(ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of gentamicin per gallon of drinking water to provide 1 mg per pound of body weight per day. Treatment may be repeated if dysentery recurs.
Indications for use.Escherichia coliBrachyspira hyodysenteriae.(2) For control and treatment of colibacillosis in weanling swine caused by strains of sensitive to gentamicin, and for control and treatment of swine dysentery…
Specifications.(a) Each packet of powder contains 8.82 grams sodium chloride, 4.20 grams potassium phosphate, 0.5 gram citric acid anhydrous, 0.12 gram potassium citrate, 6.36 grams aminoacetic acid (glycine), and 44.0 grams glucose.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in calvesAmount.(c) —(1) Dissolve each packet in 2 quarts of warm water and administer to each calf as follows:
Scouring and/or dehydrated calves.(i) Feed 2 quarts of solution, twice daily for 2 days (four feedings). No milk or milk replacer should be fed during this period. For the next four feedings (days 3 and 4), use 1 quart of solution together with 1 quart of milk replacer. Thereafter, feed as normal.
Newly purchased calves.(ii) Feed 2 quarts of solution instead of milk as the first feed upon arrival. For the next scheduled feeding, use 1 quart of solution mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal.
Indications for use.(2) For control of dehydration associated with diarrhea (scours); and as an early treatment at the first signs of scouring. It may also be used as followup treatment following intravenous fluid therapy.…
Specifications.(a) Each tablet contains 20, 60, or 100 milligrams (mg) grapiprant.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer 0.9 mg/lb (2 mg/kg) once daily by mouth.
Indications for use.(2) For the control of pain and inflammation associated with osteoarthritis in dogs.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[81 FR 36789, June 8, 2016, as amended at 83 FR 14587, Apr. 5, 2018]
Specifications.(a) A water soluble powder used to make a medicated drinking water containing apramycin sulfate equivalent to 0.375 gram of apramycin activity per gallon of drinking water.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.52 of this chapter.
Conditions of use in swineAmount.(d) —(1) Administer in drinking water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of body weight per day for 7 days.
Indications for use.Escherichia coli(2) For the control of porcine colibacillosis (weanling pig scours) caused by strains of sensitive to apramycin.
Limitations.(3) Do not slaughter treated swine for 28 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, 1988; 79 FR 28818, May 20, 2014; 81 FR 48702, July 26, 2016; 81 FR 94989, Dec. 27, 2016]
Specifications.(a) (1) The powder complies with U.S.P. for griseofulvin, microsize.
(2) Each bolus contains 2.5 grams griseofulvin.
(3) Each tablet contains 125 or 500 milligrams griseofulvin.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter.
(1) No. 000061 for use of products described in paragraph (a) for use as in paragraph (d) of this section.
(2) No. 061133 for use of the powder described in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section.
Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Conditions of useHorsesAmount and indications for use.Trichophyton equinumMicrosporum gypseum(d) —(1) —(i) (A) For equine ringworm infection caused by or , administer soluble powder described in paragraph (a)(1) of this section daily as a drench or as a top dressing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams.
T. equinum(B) For treating ringworm infection caused by , administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; yearlings,…
Specifications.(a) Each packet contains 141.5 grams haloxon.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Special considerations.(c) Do not use any drug, insecticide, pesticide, or other chemical having cholinesterase-inhibiting activity either simultaneously or within a few days before or after treatment with haloxon.
Related tolerances.(d) See § 556.310 of this chapter.
Conditions of use in cattleAmount.1/23/4 1/2(e) —(1) Dissolve each packet in 32 fluid ounces of water and administer as follows: For animals weighing up to 100 pounds: fluid ounce; for animals weighing 100 to 150 pounds: fluid ounce; for animals weighing 150 to 200 pounds: 1 fluid ounce; for animals weighing 200 to 300 pounds: 1 fluid ounces; for animals weighing 300 to 450 pounds: 2 fluid ounces; for animals weighing 450 to 700 pounds: 3 fluid ounces; for animals weighing 700 to 1,000 pounds: 4 fluid ounces; for animals weighing 1,000 to 1,200 pounds: 5 fluid ounces; for animals weighing over 1,200 pounds: 6 fluid ounces. Retreat in 3 to 4 weeks.
Indications for use.Haemonchus, Ostertagia,Trichostrongylus,Cooperia.(2) For control of gastrointestinal roundworms of the genera and…
Specifications.(a) Each bolus contains 10.1 grams of haloxon.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.310 of this chapter.
Conditions of use in cattleAmount.(d) —(1) Administered one bolus per 500 pounds body weight (35 to 50 milligrams per kilogram of body weight). Retreat in 3 to 4 weeks.
Indications for use.Haemonchus, Ostertagia,Trichostrongylus,Cooperia.(2) For control of gastrointestinal roundworms of the genera and
Limitations.(3) Do not treat dairy animals of breeding age or older. Do not treat within 1 week of slaughter.
[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28822, May 20, 2014]
Specifications.(a) Each tablet contains 100 or 400 milligrams (mg) imepitoin.
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) Administer orally twice daily, approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) of body weight. Initiate therapy starting 2 days prior to the day of the expected noise event and continuing through the noise event.
Indications for use.(2) For the treatment of noise aversion in dogs.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[84 FR 12494, Apr. 2, 2019]
Specifications.(a) Each chewable tablet contains 7.5 or 37.5 milligrams (mg) imidacloprid.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer daily one 7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 37.5-mg chewable table to dogs weighing 23 to 110 lb.
Indications for use.(2) Kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 lb or greater.
Limitations.(3) Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 lb. Do not give more than one tablet a day.
[80 FR 18775, Apr. 8, 2015, as amended at 86 FR 14818, Mar. 19, 2021]
Specifications.(a) Each 1-gram tablet contains 25 milligrams of iodinated casein.
Sponsor.(b) See No. 017762 in § 510.600(c) of this chapter.
Conditions of useAmount.1/5(c) —(1) to 1 tablet per 10 pounds of body weight (equivalent to 0.5 to 2.5 milligrams of iodinated casein per pound of body weight).
Indications for use.(2) For dogs for apparent decreased thyroid activity where the signs are alopecia, scaliness of the skin surface, loss of hair, seborrhea, thickening of the skin, hyperpigmentation, and lethargy.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[49 FR 22469, May 30, 1984, as amended at 78 FR 28822, May 20, 2014]
Specifications.(a) Each bolus contains 10 grams of iodochlorhydroxyquin.
Sponsor.(b) See No. 054771 in § 510.600 (c) of this chapter.
Conditions of useAmount.(c) —(1) 1 bolus (10 grams) daily for a 1,000-pound horse.
Indications for use.(2) For treatment of equine diarrhea.
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, 2014]
Specifications.(a) Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole.
Sponsor.(b) See No. 051311 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) Administer 5 mg/kilogram (kg) (0.5 mL/kg) of body weight once daily on alternating weeks for 3 treatment cycles.
Indications for use.Microsporum canis(2) For the treatment of dermatophytosis caused by in cats.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021]
Specifications.(a) Each milligram (mg) of paste contains 0.0187 mg (1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section:
(1) No. 000010 for use of a 1.87 percent paste as in (e)(1) of this section and a 0.153 percent paste for use as in paragraph (e)(2) of this section.
(2) Nos. 051311, 054925, 058198, and 061133 for use of a 1.87 percent paste for use as in paragraph (e)(1) of this section.
Related tolerances.(c) See § 556.344 of this chapter.
Special considerations.(d) See § 500.25 of this chapter.
Conditions of useHorsesAmount.(e) —(1) —(i) 200 micrograms per kilogram (91 micrograms per pound) of body weight.
Indications for use.Strongylus vulgarisS. edentatusS. equinusTriodontophorusT. brevicaudaT. serratusCraterostomum acuticaudatumCoronocyclusC. coronatusC. labiatusC. labratusCyathostomumC. catinatumC. pateratumCylicocyclusC. insigneC. leptostomumC. nassatusC. brevicapsulatusCylicodontophorusCylicostephanusC. calicatusC. goldiC. longibursatusC. minutusPetrovinema poculatumOxyuris equiParascaris equorumTrichostrongylus axeiHabronema muscaeGasterophilusG.…
Specifications.(a) (1) Each tablet or chewable contains 68, 136, or 272 micrograms (mcg) ivermectin.
(2) Each chewable contains 55 or 165 mcg ivermectin.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000010 for use of tablets or chewables described in paragraph (a)(1) as in paragraph (d)(1) and chewables described in paragraph (a)(2) as in paragraph (d)(2) of this section.
(2) Nos. 051311 and 069043 for use of tablets described in paragraph (a)(1) as in paragraph (d)(1) of this section.
Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Conditions of useDogs.(d) —(1) For use in dogs 6 weeks of age and older as follows:
Amount.(i) 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; over 100 lb, a combination of the appropriate tablets. Administer at monthly dosing intervals.
Indications for use.Dirofilaria immitis(ii) To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae () for 1 month (30 days) after infection.
Cats.(2) For…
Specifications.(a) Each gram of meal contains 6 milligrams ivermectin (0.6 percent).
Sponsor.(b) See No. 017135 in § 510.600(c) of this chapter.
Special considerations.(c) See § 500.25 of this chapter.
Conditions of use in horsesAmount.(d) —(1) Administer 136 micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/kilogram) as a single dose on approximately 2 lb grain or sweet feed.
Indications for use.Strongylus vulgarisS.edentatusS.equinusTriodontophorusT.brevicaudaT.serratusCraterostomum acuticaudatumCoronocyclusC.coronatusC.labiatusC.labratusCyathostomumC.catinatumC.pateratumCylicocyclusC.insigneC.leptostomumC.nassatusC.brevicapsulatusCylicodontophorusCylicostephanusC.calicatusC.goldiC.longibursatusC.minutusPetrovinema poculatumOxyuris equiParascaris equorumTrichostrongylus axeiHabronema muscaeasterophilusG.intestinalisG.nasalisDictyocaulus arnfieldiStrongyloides westeriHabronemaDraschiaOnchocerca(2) For treatment and control of Large Strongyles (adults): (also early forms in blood vessels), (also tissue stages), , spp. including and , and ; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): spp. including , , and , spp.…
Specifications.(a) (1) Each milliliter (mL) contains 10 milligrams (mg) ivermectin.
(2) Each mL of micellar solution contains 0.8 mg ivermectin.
Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter.
(1) Nos. 054925, 058005, and 058198 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
(2) No. 058829 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section.
(3) Nos. 000010 and 058829 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.
Related tolerances.(c) See § 556.344 of this chapter.
Special considerations.(d) See § 500.25 of this chapter.
Conditions of useHorsesAmount.(e) —(1) —(i) 200 micrograms (mcg) per kilogram (/kg) of body weight as a single dose by stomach tube or as an oral drench.
Indications for use.(ii) For treatment and control of:
Strongylus vulgarisS. edentatusS. equinusTriodontophorusT. brevicaudaT. serratusCraterostomum acuticaudatumCoronocyclusC. coronatusC. labiatusC. labratusCyathostomumC. catinatumC.…
Specifications.(a) Each chewable tablet contains either 68 micrograms (µg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 µg and 114 mg, or 272 µg and 227 mg, respectively.
Sponsors.(b) See Nos. 000010, 051311, and 063604 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) Administer a minimum of 6 µg of ivermectin and 5 mg of pyrantel per kilogram (2.72 µg and 2.27 mg per pound) of body weight monthly.
Indications for use.Dirofilaria immitisToxocara canisToxascaris leonina,Ancylostoma caninum, A. braziliense,Uncinaria stenocephala.(ii) To prevent canine heartworm disease by eliminating the tissue larval stages of for up to a month (30 days) after infection and treatment and control of adult roundworms and and adult hookworms and
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014; 84 FR 39183, Aug. 9, 2019; 88 FR 16547, Mar. 20,…
Specifications.(a) Each sustained-release bolus contains 1.72 grams of ivermectin.
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
Related tolerances. See § 556.344 of this chapter.(c)
Conditions of use in ruminating calvesAmount.(d) —(1) Administer one bolus per calf weighing at least 275 pounds (lb) (125 kilograms (kg)) and not more than 660 lb (300 kg) on the day of administration.
Indications.Haemonchus placei, Ostertagia ostertagiTrichostrongylus axei, T. colubriformis, CooperiaNematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum radiatum;Dictyocaulus viviparus;HypodermaLinognathus vituli, Solenopotes capillatus;Psoroptes ovis, Sarcoptes scabiei,Amblyomma americanum.(2) For treatment and control, throughout the grazing season (approximately 130 days), of gastrointestinal roundworms (including inhibited fourth-stage larvae), spp., lungworms grubs spp.; sucking lice mange mites and ticks
Limitations.(3) The bolus was specifically designed for use in cattle; do not use in other animal species. Calves must be ruminating and older than 12 weeks of age. Do not administer to calves weighing less than 275 lb (125 kg). Do not administer a damaged bolus.…
Specifications.(a) Each milligram (mg) of paste contains:
(1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel.
(2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel.
(3) 0.0187 mg (1.87 percent) ivermectin and 0.2338 mg (23.38 percent) praziquantel.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.—
(1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this section.
(2) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this section.
(3) No. 000010 for use of products described in paragraph (a)(3) of this section as in paragraphs (d)(1)(iii), (d)(2)(iii) and (d)(3) of this section.
Special considerations.(c) See § 500.25 of this chapter.
Conditions of use in horsesAmount.(d) —(1) (i) 200 micrograms (mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg praziquantel (454 mcg/lb) body weight.
(ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel (681 mcg/lb) body weight.
(iii)…
§ 520.1199Ivermectin, pyrantel, and praziquantel tablets.
Specifications.(a) Each chewable tablet or soft chewable tablet contains:
(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel;
(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel;
(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or
(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.
Sponsor.(b) See No. 051311 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer monthly according to body weight as follows:
(i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section.
(ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section.
(iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section.
(iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section.
(v) Greater than 100 lb: use the appropriate combination of tablets.
Indications for use.Dirofilaria immitisToxocara canis, Toxascaris leoninaAncylostoma caninum, Uncinaria stenocephala, Ancylostoma brazilienseDipylidium caninum, Taenia pisiformis(2) To prevent canine heartworm disease by eliminating the…
§ 520.1200Ivermectin, fenbendazole, and praziquantel tablets.
Specifications.(a) Each chewable tablet contains either:
(1) 68 micrograms (µg) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or
(2) 27 µg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer tablets to provide 6 µg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel.
Indications for use.Toxocara canisAncylostoma caninumTrichuris vulpisDipylidium caninumDirofilaria immitis(2) For the treatment and control of adult (roundworm), (hookworm), (whipworm), and (tapeworm), and for the prevention of heartworm disease caused by in adult dogs.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009]
§ 520.1204attapulgite. 7462 § 520.1204 Kanamycin, bismuth subcarbonate, activated
Specifications.(a) (1) Each 5 milliliters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite (aluminum magnesium silicate).
(2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.1/2(c) —(1) 5 mL of suspension or 1 tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of suspension or tablet every 8 hours. A recommended initial loading dose should be twice the amount of a single dose.
Indications for use.(2) For the treatment of bacterial enteritis caused by organisms susceptible to kanamycin and the symptomatic relief of the associated diarrhea.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 3, 2006; 78 FR 28822, May 20, 2014]
Specifications.(a) Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.
Sponsors.(b) See sponsors in § 510.600(c) for use as follows:
(1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 46.8-, and 544.5-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for an 18.15-g package as in paragraph (e)(3) of this section.
(2) No. 054771 for use of a 46.8-g package as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in paragraph (e)(3) of this section.
(3) No. 016592 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section.
(4) No. 061133 for use of 46.8-, 362.7-, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-g package as in…
Specifications.(a) Each bolus contains 2.19 grams levamisol hydrochloride. Each oblet contains 0.184 grams levamisol hydrochloride.
Sponsors.(b) See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
Required labeling.(c) Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
Related tolerances.(d) See § 556.350 of this chapter.
Conditions of useCattleAmount.1/21/2(e) —(1) —(i) Administer orally 2.19-gram boluses as a single dose as follows: 250 to 450 pounds, bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1 boluses.
Indications for use.Haemonchus, Trichostrongylus,OstertagiaTrichostrongylus, Cooperia,Nematodirus, Bunostomum,OesophagostomumDictyocaulus(ii) Anthelmintic effective against the following nematode infections: Stomach worms ( ), intestinal worms ( ), and lungworms ().
Limitations.(iii) Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Consult veterinarian before using in severely debilitated animals.
SheepAmount.(2) —(i) Administer orally one…
Specifications.(a) (1) Each ounce of solution contains 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.
(2) A soluble powder which when constituted with water contains in each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in horsesAmount.(c) —(1) Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals.
Indications for use.Strongylus vulgaris, S. edentatusCylicocercusCylicocyclusCylicodontophorusCylicostephanusCylicotetrapedonParascaris equorumOxyuris equi(2) An anthelmintic effective against infections of large strongyles (), small strongyles ( spp., spp., spp., spp., spp.), ascarids (), and pinworms ().
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed…
Specifications.(a) The drug is levamisole adsorbed on a resin, in a concentration equivalent to 10 percent levamisole hydrochloride. Each 2.05-ounce (58.1 gram) packet contains levamisole equivalent to 5.806 grams of levamisole hydrochloride.
Sponsor.(b) See No. 043781 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.350 of this chapter.
Conditions of use.(d) In swine it is used as follows:
Amount.(1) The equivalent of 8 milligrams per kilogram of body weight, as a single dose, mixed in the animal's ration.
Indications for use.Ascaris suumOesophagostomumMetastrongylusStrongyloides ransomiStephanurus dentatum(2) For the removal of and control of the following nematode infections: large roundworms (), nodular worms ( spp.), lungworms ( spp.), intestinal threadworms (), and swine kidney worms ().
Limitations.(3) For pigs from weaning to market weight, mix one 58.1-gram packet of levamisole resinate containing the equivalent of 10-percent levamisole hydrochloride in 40 pounds of feed and administer 1 pound of medicated feed per 40 pounds of body weight as sole ration. For breeding swine, mix 1 packet of the 10-percent resinate in 16 pounds of feed and administer…
§ 520.1242eLevamisole hydrochloride effervescent tablets.
Specifications.(a) Each tablet contains 907 milligrams of levamisole hydrochloride.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.350 of this chapter.
Conditions of use.(d) It is used for swine as follows:
Amount.(1) The equivalent of 8 milligrams of levamisole hydrochloride per kilogram of body weight, as a single dose.
Indications for use.(2) See § 520.1242a(f)(3)(ii).
Limitations.1/2(3) Withholding water from pigs before treatment is not necessary. Add one tablet for each 2 gallons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular water. Pigs maintained under conditions of constant worm exposure may require re-treatment within 4 to 5 weeks. Consult your veterinarian before administering to sick swine. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not administer within 72 hours of slaughter for food.
[45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014]
Specifications.(a) Each gram of gel contains 115 milligrams (11.5 percent) levamisol hydrochloride.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.350 of this chapter.
Conditions of useCattleAmount.(d) —(1) —(i) Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose.
Indications for use.Haemonchus, Trichostrongylus, OstertagiaTrichostrongylus, Cooperia, Nematodirus, Bunostomum, OesophagostomumDictyocaulus(ii) Anthelmintic effective against the following nematode infections: Stomach worms (), intestinal worms (), and lungworms ().
Limitations.(iii) Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not administer to cattle within 6 days of slaughter for food; do not administer to dairy animals of breeding age; consult veterinarian before using in severely debilitated animals.
Breeding swineAmount.(2) —(i) Eight milligrams per kilogram of body weight (3.6 milligrams per pound) as a single oral dose.
Conditions of use.Ascaris suumOesophagostomumMetastrongylusStrongyloides ransomiStephanurus dentatus(ii) For treating breeding…
Specifications.(a) The drug is a paste containing 11.6 percent levamisole resinate (50 percent potency) and 23.6 percent famphur.
Sponsor.(b) See 000061 in § 510.600(c) of this chapter.
Special considerations.(c) Do not use any cholinesterase-inhibiting drugs, pesticides, insecticides, or chemicals on cattle simultaneously or within a few days before or after treatment with this product.
Related tolerances.(d) See §§ 556.273 and 556.350 of this chapter.
Conditions of use in cattleAmount.(e) —(1) 8 milligrams of levamisole hydrochloride (equivalent) and 30 milligrams of famphur activity per kilogram of body weight.
Indications for use.Haemonchus, Trichostrongylus, OstertagiaTrichostrongylus, Cooperia, Nematodirus, Bunostomum, OesophagostomumDictyocaulusHypodermaBovicolaLinognathus, Solenoptes(2) For treatment of cattle infected with the following parasites: Stomach worms (), intestinal worms (), lungworms (), cattle grubs (), biting lice (), and sucking lice ().
Limitations.(3) Drug is not effective against lice eggs. Conditions of constant helminth and ectoparasitic exposure may require retreatment within 2 to 4 weeks after first treatment. Do not administer to cattle within…
Specifications.(a) Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.
Sponsors.(b) See Nos. 059051 and 061690 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) Administer by mouth as follows:
(i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/kilogram (kg)) as a single dose every 24 hours or as a divided dose every 12 hours.
(ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.
Indications for use.(2) For replacement therapy for diminished thyroid function in dogs.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[81 FR 22523, Apr. 18, 2016, as amended at 86 FR 57996, Oct. 20, 2021]
Specifications.(a) (1) Each ounce of syrup contains lincomycin hydrochloride equivalent to either 25 or 50 milligrams (mg) lincomycin.
(2) Each tablet contains lincomycin hydrochloride equivalent to either 25 or 50 mg lincomycin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogs and catsAmount.(c) —(1) Administer orally 10 mg per pound of body weight every 12 hours, or 7 mg per pound of body weight every 8 hours, for up to 12 days.
Indications for use.(2) For infections caused by gram-positive organisms which are sensitive to its action, particularly streptococci and staphylococci.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[78 FR 28823, May 20, 2014]
Specifications.(a) Each gram of soluble powder contains lincomycin hydrochloride equivalent to 0.4 grams of lincomycin.
Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) Nos. 054771 and 061133 for use as in paragraph (d) of this section.
(2) Nos. 016592, 054925, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section.
Tolerances.(c) See § 556.360 of this chapter.
Conditions of useSwineAmount.(d) —(1) —(i) 250 milligrams per gallon of drinking water to provide 3.8 milligrams per pound of body weight per day.
Indications for use.(ii) For the treatment of swine dysentery (bloody scours).
Limitations.(iii) Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not improved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. For No. 054925: Do not slaughter swine for 6 days following last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
ChickensAmount.(2) —(i) 64…
Specifications.(a) The following salts of lincomycin and spectinomycin are present in a soluble powder in the ratio of 1 to 2 on the basis of equivalency of lincomycin base to equivalency of spectinomycin base:
(1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate.
(2) Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 054771 for use of product described in paragraph (a)(1) of this section.
(2) Nos. 016592, 061133, and 066104 for use of product described in paragraph (a)(2) of this section.
Tolerances.(c) See §§ 556.360 and 556.600 of this chapter.
Conditions of use in chickensAmount.(d) —(1) 2 grams of antibiotic activity per gallon of drinking water; administer as the sole source of water for the first 5 to 7 days of life.
Indications for use.Mycoplasma synoviaeM. gallisepticumEscherichia coliM. gallisepticum(2) As an aid in the control of airsacculitis caused by either or susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by and susceptible to…
Specifications.(a) Each tablet contains 60 or 120 micrograms (µg) liothyronine as the sodium salt.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally to dogs at levels up to 12.8 µg per kilogram (/kg) of body weight per day. Dosage should be adjusted according to the severity of the condition and the response of the patient. Dosage at the total replacement level (12.8 µg/kg of body weight) should be considered for initiating therapy and then titrated downward for optimum maintenance effect. Twice daily administration is recommended.
Indications for use.(2) For treatment of hypothyroidism in dogs.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[78 FR 28823, May 20, 2014]
Specifications.(a) Each pound of soluble powder contains the equivalent of 50 grams of bacitracin activity for use as in paragraph (d)(1) or (d)(2) of this section, or the equivalent of 200 grams of bacitracin activity for use as in paragraph (d) of this section.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.70 of this chapter.
Conditions of useBroiler and replacement chickensAmount.(d) —(1) —(i) 100 mg per gal in drinking water.
Indications for use.Clostridium perfringens(A) Aid in the prevention of necrotic enteritis caused by susceptible to bacitracin methylenedisalicylate.
Limitations.(B) Prepare a fresh solution daily. Use as the sole source of drinking water.
Amount.(ii) 200 to 400 mg per gal in drinking water. Administer continuously 5 to 7 days or as long as clinical signs persist, then reduce to prevention levels (100 mg/gal).
Indications for use.C. perfringens(A) Treatment of necrotic enteritis caused by susceptible to bacitracin methylenedisalicylate.
Limitations.(B) Prepare a fresh solution daily. Use as the sole source of drinking water.
Growing turkeysAmount.(2) —(i) 400 milligrams (mg) per gallon (gal) in…
§ 520.154bBacitracin methylenedisalicylate and streptomycin sulfate powder.
Specifications.(a) Each gram of powder contains 200 units bacitracin methylenedisalicylate and streptomycin sulfate equivalent to 20 milligrams of streptomycin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed.
Indications for use.Escherichia coli, ProteusStaphylococcusStreptococcus(2) For the treatment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as spp., spp., and spp., and for the symptomatic treatment of associated diarrhea.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[71 FR 17702, Apr. 7, 2006, as amended at 79 FR 28818, May 20, 2014; 81 FR 17607, Mar. 30, 2016]
Specifications.(a) Each pound contains the equivalent of not less than 5 grams of bacitracin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.70 of this chapter.
Conditions of useBroiler chickensAmount.(d) —(1) —(i) 100 milligrams per gallon in drinking water.
Indications for use.Clostridium perfringens(A) Prevention of necrotic enteritis caused by susceptible to bacitracin zinc.
Limitations.(B) Prepare a fresh solution daily.
Amount.(ii) 200 to 400 milligrams per gallon in drinking water.
Indications for use.Clostridium perfringens(A) Control of necrotic enteritis caused by susceptible to bacitracin zinc.
Limitations.(B) Prepare a fresh solution daily.
Growing quailAmount.(2) —(i) 500 milligrams per gallon in drinking water for 5 days followed by 165 milligrams per gallon in drinking water for 10 days.
Indications for use.Clostridium(ii) Control of ulcerative enteritis caused by spp. susceptible to bacitracin zinc.
Limitations.(iii) Prepare a fresh solution daily.
[57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, 2014]
Specifications.(a) Each tablet contains 15 milligrams bexagliflozin.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) Administer one tablet by mouth to cats 6.6 lb (3.0 kg) or greater once daily, at approximately the same time each day, with or without food, and regardless of blood glucose level.
Indications for use.(2) To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[88 FR 16547, Mar. 20, 2023]
Chemical name. N,N(a) -Dibutyl-4-(hexyloxy)-1-naphthamidine hydrochloride.
Specifications.(b) The drug is an oral tablet containing 100, 200, or 400 milligrams of bunamidine hydrochloride.
Sponsor.(c) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use.Dipylidium caninum, Taenia pisiformis,Echinococcus granulosus,Dipylidium caninumTaenia taeniaeformis.(d) (1) The drug is intended for oral administration to dogs for the treatment of the tapeworms and and to cats for the treatment of the tapeworms and
(2) It is administered to cats and dogs at the rate of 25 to 50 milligrams per kilogram of body weight. The drug should be given on an empty stomach and food should not be given for 3 hours following treatment.
(3) Tablets should not be crushed, mixed with food, or dissolved in liquid. Repeat treatments should not be given within 14 days. The drug should not be given to male dogs within 28 days prior to their use for breeding. Do not administer to dogs or cats having known heart conditions.
(4) For use only by or on the order of a licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar.…
Specifications.(a) Each tablet contains 5, 10, or 25 milligrams (mg) acepromazine maleate.
Sponsors.(b) See No. 000010 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) 0.25 to 1.0 mg per pound (/lb) body weight orally.
Indications for use.(ii) As an aid in tranquilization and as a preanesthetic agent.
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CatsAmount.(2) —(i) 0.5 to 1.0 mg/lb body weight orally.
Indications for use.(ii) As a tranquilizer.
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[75 FR 10165, Mar. 5, 2010]
Specifications.(a) Each tablet contains butorphanol tartrate equivalent to 1, 5, or 10 milligrams (mg) butorphanol base.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer 0.25 mg butorphanol base per pound of body weight. Repeat at intervals of 6 to 12 hours as required. Treatment should not normally be required for longer than 7 days.
Indications for use.(2) For the relief of chronic nonproductive cough associated with tracheobronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28818, May 20, 2014]
Specifications.n(a) Each capsule contains 221, 442, 884, or 1,768 milligrams (mg); or 4.42 grams of -butyl chloride.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter:
(1) No. 023851 for capsules containing 221, 442, 884, or 1,768 mg, or 4.42 grams (g); and
(2) No. 054771 for capsules containing 221 mg.
Conditions of use in dogsAmount.(c) —(1) Administer capsules orally based on body weight as follows:
1/4(i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1 pounds of body weight.
1/2(ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2 pounds of body weight.
(iii) Capsules containing 884 mg:
(A) Under 5 pounds, 1 capsule;
(B) 5 to 10 pounds, 2 capsules;
(C) 10 to 20 pounds, 3 capsules;
(D) 20 to 40 pounds, 4 capsules;
(E) Over 40 pounds, 5 capsules.
(iv) Capsules containing 1,768 mg: Dogs weighing 5 to 10 pounds, 1 capsule.
(v) Capsules containing 4.42 g: Dogs weighing 40 pounds or over, 1 capsule.
Indications for use.Toxocara canisToxascaris leoninaAncylostoma caninum, Ancylostoma braziliense,Uncinaria stenocephala(2) For the removal of ascarids ( and ) and hookworms ( and ) from dogs.
Limitations.1/2(3) Dogs should not be fed for 18…
Specifications.(a) A powder containing acetazolamide sodium, USP equivalent to 25 percent acetazolamide activity.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally at a dosage of 5 to 15 milligrams per pound of body weight daily.
Indications for use.(2) As an aid in the treatment of mild congestive heart failure and for rapid reduction of intraocular pressure.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28816, May 20, 2014]
Specifications.(a) Each milliliter of solution contains:
(1) 30 milligrams (mg) capromorelin; or
(2) 20 mg capromorelin.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of useDogs.(c) —(1) Use product described in paragraph (a)(1) of this section as follows:
Amount.(i) Administer 3 mg/kg once daily by mouth.
Indications for use.(ii) For appetite stimulation in dogs.
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats.(2) Use product described in paragraph (a)(2) of this section as follows:
Amount.(i) Administer 2 mg/kg once daily by mouth.
Indications for use.(ii) For management of weight loss in cats with chronic kidney disease.
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[81 FR 59133, Aug. 29, 2016, as amended at 85 FR 4207, Jan. 24, 2020; 86 FR 17063, Apr. 1, 2021]
§ 520.301Caramiphen ethanedisulfonate and ammonium chloride tablets.
Specifications.(a) Each tablet contains 10 milligrams of 5st caramiphen ethanedisulfonate and 80 milligrams of ammonium chloride.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) One tablet per 15 to 30 pounds of body weight every 4 to 6 hours.
Indications for use.(2) For relief of cough.
[43 FR 55385, Nov. 28, 1978, as amended at 79 FR 28819, May 20, 2014. Redesignated at 80 FR 13229, Mar. 13, 2015]
Specifications.(a) Each tablet contains 10 milligrams of carnidazole.
Sponsor.(b) See 053923 in § 510.600(c) of this chapter.
Conditions of useAmount.1/2(c) —(1) Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: tablet (5 milligrams).
Indications for use.(2) For treating trichomoniasis (canker) in ornamental and homing pigeons.
Limitations.(3) Not for use in pigeons intended for human food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism or when severely ill birds do not respond to treatment.
[54 FR 32336, Aug. 7, 1989. Redesignated at 80 FR 13229, Mar. 13, 2015]
Specifications.(a) (1) Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.
(2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
(3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) Nos. 017033, 054771, 055529, 062250, and 086101 for use of products described in paragraph (a)(1) and (2) of this section as in paragraph (c) of this section.
(2) Nos. 058198 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.
(3) No. 069043 for use of product described in paragraph (a)(3) of this section as in paragraph (c) of this section.
Conditions of use in dogsAmount.(c) —(1) 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.
Indications for use.(2) For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
Limitations.(3) Federal Law restricts this drug to use by or on the order…
Specifications.(a) (1) Each tablet contains 50, 100, or 200 milligrams (mg) or 1 gram of cefadroxil.
(2) Each milliliter of suspension constituted from powder contains 50 mg of cefadroxil.
Sponsor.(b) See No. 042791 in § 510.600(c) of this chapter.
Conditions of use in dogs and catsAmountDogs.(c) —(1) —(i) Administer 10 mg per pound (/lb) body weight twice daily orally.
Cats.(ii) Administer 10 mg/lb body weight once daily orally.
Indications for useDogs.Staphylococcus aureus.Escherichia coliProteus mirabilisS. aureus.(2) —(i) For the treatment of skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections, and abscesses due to susceptible strains of For the treatment of genitourinary tract infections (cystitis) due to susceptible strains of , , and
Cats.Pasteurella multocidaS. aureusStaphylococcus epidermidisStreptococcus(ii) For the treatment of skin and soft tissue infections including abscesses, wound infections, cellulitis, and dermatitis caused by susceptible strains of , , , and spp.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[75 FR 10165, Mar. 5, 2010, as amended at 87 FR…
Specifications.(a) (1) Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime.
(2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for uses as follows:
(1) No. 017033 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section.
(2) No. 054771 for use of products in paragraph (a) of this section as in paragraph (c) of this section.
Conditions of use in dogsAmount.(c) —(1) 5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.
Indications for use.Staphylococcus pseudintermediusS. aureusStreptococcus canisEscherichia coliPasteurella multocidaProteus mirabilis.(2) For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of , , (group G, beta-hemolytic), , , and
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, 2014; 80…
Specifications.(a) Each chewable tablet contains 75, 150, 300, or 600 milligrams (mg) cephalexin.
Sponsor.(b) See No. 051311 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) Administer 22 mg per kilogram of body weight twice daily for 28 days.
Indications for use.Staphylococcus pseudintermedius.(ii) For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[77 FR 47512, Aug. 9, 2012]
Specifications.(a) Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.
Sponsor.(b) See No. 054771 in § 510.600 of this chapter.
Related tolerances.(c) See § 556.34 of this chapter.
Special considerations.(d) See § 500.25 of this chapter.
Conditions of useCattle.(e) —(1) Administer 11.36 percent suspension:
Amount.(i) 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a single oral dose using dosing gun or dosing syringe.
Indications for use.Fasciola hepaticaMoniezia benedeniM. expansaOstertagia ostertagiHaemonchus contortusH. placeiTrichostrongylus axeiNematodirus spathigerN. helvetianusCooperia punctataC. oncophoraBunostomum phlebotomumTrichostrongylus colubriformisOesophagostomum radiatumDictyocaulus viviparus(ii) For removal and control of adult liver flukes (); heads and segments of tapeworms ( and ); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (), barberpole worm ( and ), small stomach worm ()); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm ( and ), small intestinal worm ( and )); adult stages of intestinal worms…
Specifications.(a) The product contains 30 percent albendazole.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.34 of this chapter.
Conditions of use in cattleAmount.(d) —(1) Equivalent to 4.54 milligrams per 1 pound of body weight (10 milligrams per kilogram).
Indications for use.Fasciola hepaticaMoniezia benedeni, M. expansaOstertagia ostertagiHaemonchus contortus, H. placeiTrichostrongylus axeiNematodirus spathiger, N. helvetianusCooperia punctataC. oncophoraBunostomum phlebotmumTrichostrongylus colubriformisOesophagostomum radiatumDictyocaulus viviparus(2) For removal and control of the following internal parasites of cattle: adult liver flukes (); heads and segments of tapeworms (); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (); barberpole worm (); small stomach worm ()); adult and 4th stages larvae of intestinal worms (thread-necked intestinal worm (); small intestinal worm ( and )); adult stages of intestinal worms (hookworm (); bankrupt worm (), nodular worm ()); adult and 4th stage larvae of lungworms ().
Limitations.(3) Administer as a single oral dose. Do not…
Specifications.(a) Each tablet contains 50, 100, 250, or 500 milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.
Sponsors.(b) See § 510.600(c) of this chapter:
(1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section:
(i) No. 069043 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets;
(ii) No. 054771 for 100-, 250-, and 500-mg tablets;
(2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section:
(i) No. 061133 for 50-, 100-, 250-, and 500-mg; and 1-g tablets;
(ii) [Reserved]
Conditions of use in dogsAmount.(c) —(1) Administer 25 mg per pound of body weight by mouth every 6 hours.
Indications for use(2) —(i) For the treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
(ii) For the treatment of bacterial gastroenteritis associated with bacterial diarrhea, bacterial pulmonary infections, and bacterial infections of the urinary tract caused by susceptible organisms.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the…
Specifications.(a) Each capsule contains 50, 100, 250, or 500 milligrams (mg) chloramphenicol.
Sponsors.(b) See Nos. 050057 and 054771 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
Special considerations.(c) Federal law prohibits the extralabel use of this product in food-producing animals.
Conditions of use in dogsAmount.(d) —(1) 25 mg per pound of body weight every 6 hours.
Indications for use.(2) For treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[70 FR 75398, Dec. 20, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 2010; 79 FR 28819, May 20, 2014]
§ 520.390cChloramphenicol palmitate oral suspension.
Specifications.(a) Each milliliter contains chloramphenicol palmitate equivalent to 30 milligrams of chloramphenicol.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use. DogsAmount.(c) —(1) 25 milligrams per pound of body weight every 6 hours. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.
Indications for use.(2) Treatment of bacterial pulmonary infections, infections of the urinary tract, enteritis, and infections associated with canine distemper that are caused by organisms susceptible to chloramphenicol.
Limitations.(3) Not for use in animals that are raised for food production. Must not be used in meat-, egg-, or milk-producing animals. The length of time that residues persist in milk or tissues has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 79 FR 28819, May 20, 2014]
Specifications.(a) Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) Administer orally once a month at a minimum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)).
Indications for use.Ctenocephalides felisIxodes scapularisDermacentor variabilisAmblyomma americanumRhipicephalus sanguineusBorrelia burgdorferiIxodes scapularis(2) Kills adult fleas; for the treatment and prevention of flea infestations (); for the treatment and control of black-legged tick (), American dog tick (), lone star tick (), and brown dog tick () infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of infections as a direct result of killing vector ticks.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[78 FR 66264, Nov. 5, 2013, as amended at 79 FR 37619, July 2, 2014; 84 FR 8972, Mar. 13, 2019; 84 FR 39182, Aug. 9, 2019]
Specifications.(a) Each tablet contains 400 milligrams of chlorphenesin carbamate.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) 50 milligrams per pound of body weight on first day; 25 milligrams per pound of body weight each following day. Divide total daily dose into 2 or 3 equal doses—administer at 12- or 8-hour intervals.
Indications for use.(2) For use as an adjunct to therapy of acute inflammatory and traumatic conditions of skeletal muscles. The drug provides relief of the signs of discomfort associated with myositis, muscle sprains, traumatic injuries, stifle injuries—especially when administered before or after surgery—and invertebral disc syndrome (can be used concurrently with adrenal corticosteroids).
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[44 FR 16009, Mar. 16, 1979, as amended at 79 FR 28819, May 20, 2014]
Specifications.(a) Chlortetracycline powder contains not less than 15 milligrams per gram chlortetracycline hydrochloride, or chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline hydrochloride.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 069254 for use as in paragraph (d) of this section.
(2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section.
(3) Nos. 069043 and 076475 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) and (iii) of this section.
Related tolerances.(c) See § 556.150 of this chapter.
Conditions of use.(d) (1) Use as chlortetracycline hydrochloride in drinking water as follows:
SwineAmount.(i) —(A) Ten milligrams per pound of body weight daily in divided doses.
1Indications for use.Escherichia coliPasteurellaActinobacillus pleuropneumoniaeHaemophilusKlebsiella() Control and treatment of bacterial enteritis (scours) caused by and bacterial pneumonia associated with spp., ( spp.), and spp.
2) Limitations.( Prepare a fresh solution…
§ 520.443Chlortetracycline tablets and boluses.
Specifications.(a) Each tablet contains 25 milligrams (mg) chlortetracycline hydrochloride; each bolus contains 250 or 500 mg chlortetracycline hydrochloride.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 069043 for use of a 250-mg bolus as in paragraph (d)(1) of this section.
(2) No. 016592 for use of a 25-mg tablet as in paragraph (d)(2) of this section.
(3) No. 016592 for use of a 500-mg bolus as in paragraph (d)(3) of this section.
Related tolerances.(c) See § 556.150 of this chapter.
Conditions of use in calvesAmount.(d) —(1) One 250 milligram bolus per 50 pounds of body weight twice a day for 3 to 5 days.
Indications for use.Escherichia coliPasteurellaKlesbsiellaHaemophilus(i) Treatment of bacterial enteritis (scours) caused by and bacterial pneumonia associated with spp., spp., and spp.
Limitations.(ii) Administer bolus directly by mouth or crush and dissolve in milk or water for drenching or bucket feeding; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter.
Amount.(2) One 25 milligram tablet…
§ 520.445Chlortetracycline and sulfamethazine powder.
Specifications.(a) Each pound of soluble powder contains chlortetracycline bisulfate equivalent to 102.4 grams (g) of chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent to 102.4 g of sulfamethazine.
Sponsor.(b) See No. 016592 in § 510.600(c) of this chapter.
Related tolerances.(c) See §§ 556.150 and 556.670 of this chapter.
Conditions of use in swine.(d) Administer in drinking water as follows:
Amount.(1) 250 milligrams (mg) of chlortetracycline and 250 mg of sulfamethazine per gallon.
Indications for use.(2) For the prevention and treatment of bacterial enteritis; as an aid in the reduction of the incidence of cervical abscesses; and as an aid in the maintenance of weight gains in the presence of bacterial enteritis and atrophic rhinitis.
Limitations.(3) Use as the sole source of chlortetracycline and sulfonamide. Not to be used for more than 28 consecutive days. Withdraw 15 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[76 FR 49649, Aug. 11, 2011, as amended at 81 FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016]
Specifications.(a) (1) Each capsule contains the equivalent of 25, 75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.
(2) Each tablet contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.
(3) Each capsule contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 054771 and 069043 for use of capsules described in paragraph (a)(1) of this section.
(2) No. 051311 for use of tablets described in paragraph (a)(2) of this section.
(3) No. 043806 for use of tablets described in paragraph (a)(3) of this section.
Conditions of use in dogsAmount.(c) —(1) Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.
Indications for use.Staphylococcus aureusS. intermediusBacteroides fragilisPrevotella melaninogenicusFusobacterium necrophorumClostridium perfringensS. aureusB. fragilisP. melaninogenicusF. necrophorumC. perfringensS. aureusB. fragilisP. melaninogenicusF. necrophorumC.…
Specifications.(a) Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
Sponsors.(b) See Nos. 051311, 054771, 058829, 061133, and 069043 in § 510.600(c) of this chapter.
Special considerations.(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Conditions of useDogsAmount.(d) —(1) —(i) Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.
Indications for use.Staphylococcus aureusS. intermediusBacteroides fragilisPrevotella melaninogenicusFusobacterium necrophorumClostridium perfringensS. aureusB. fragilisP. melaninogenicusF. necrophorumC. perfringensS. aureusB. fragilisP. melaninogenicusF. necrophorumC. perfringens.(ii) For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( or ), deep wounds and abscesses due to susceptible strains of , , , and ; dental infections due to susceptible strains of , , , , and ; and osteomyelitis due to susceptible strains of , , ,…
Specifications.(a) Each milliliter contains 72.5 micrograms of clenbuterol hydrochloride.
Sponsor.(b) See 000010 in § 510.600(c) of this chapter.
(c) [Reserved]
Conditions of useHorsesAmount.(d) —(1) —(i) Administer orally twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1 milliliter per 100 pounds (1.6 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milliliters per 100 pounds (2.4 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 2.0 milliliters per 100 pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no improvement, horse is nonresponder to clenbuterol and treatment should be discontinued.
Indications for use.(ii) Indicated for the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).
Limitations.(iii) Treat at effective dose for 30 days. At the end of the 30-day treatment period, drug should be withdrawn. If signs return, the 30-day treatment period may be repeated. If repeating treatment, the step-wise…
(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.
Sponsors.(b) See Nos. 051311 and 086039 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.
Indications for use.(2) For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021]
Specifications.(a) The drug is a suspension containing 8.5 percent clorsulon (85 milligrams per milliliter).
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.163 of this chapter.
Conditions of use. CattleAmount.(d) —(1) One-quarter fluid ounce per 200 pounds of body weight (7 milligrams per kilogram or 3.2 milligrams per pound of body weight).
Indications for use.Fasciola hepatica(2) For the treatment of immature and adult liver fluke () infestations in cattle.
Limitations.(3) Using dose syringe, deposit drench over back of tongue. Do not treat cattle within 8 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
[50 FR 10221, Mar. 14, 1985, as amended at 62 FR 63270, Nov. 28, 1997; 84 FR 32992, July 11, 2019; 84 FR 39183, Aug. 9, 2019]
Specifications.(a) Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter:
(1) Nos. 000061 and 051072 for use as in paragraph (d) of this section.
(2) No. 061133 for use as in paragraph (d)(1) of this section.
(3) No. 013744 for use as in paragraph (d)(2) of this section.
Tolerances.(c) See § 556.36 of this chapter.
HorsesAmount.(d) Conditions of use—(1) —(i) 1.0 mL per 110 pounds body weight (0.044 mg/kg) daily for 15 consecutive days.
Indications for use.(ii) For suppression of estrus in mares.
Limitations.(iii) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
SwineAmount.(2) —(i) Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days by top-dressing on a portion of each gilt's daily feed.
Indications for use.(ii) For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.
Limitations.(iii) Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be…
Specifications.(a) (1) Each cyclosporine capsule, USP (MODIFIED) contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.
(2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) contains 100 mg cyclosporine.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter.
(1) No. 058198 for use of products described in paragraph (a) as in paragraph (d) of this section.
(2) No. 017033 for use of product described in paragraph (a)(1) as in paragraph (d)(1) of this section.
(3) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1) of this section.
(4) No. 086097 for use of product described in paragraph (a)(2) as in paragraph (d) of this section.
(c) [Reserved]
Conditions of useDogs.(d) —(1) Use capsules described in paragraph (a)(1) of this section as follow:
Amount.(i) Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.
Indications…
Specifications.(a) Each milliliter contains 15 milligrams of cythioate.
Sponsor.(b) See Nos. 054771 and 058198 in § 510.600 of this chapter.
Conditions of useAmount.(c) —(1) 15 milligrams cythioate per 10 pounds of body weight every third day or twice a week.
Indications for use.(2) Dogs, for control of fleas.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014; 86 FR 14818, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022]
Specifications.(a) Each tablet contains 30 or 90 milligrams (mg) cythioate.
Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) No. 058198 for use of 30- and 90-mg tablets.
(2) No. 054771 for use of the 30-mg tablet.
Conditions of useAmount.(c) —(1) 30 milligrams cythioate per 20 pounds of body weight every third day or twice a week.
Indications for use.(2) Dogs, for control of fleas.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014; 86 FR 14818, Mar. 19, 2021]
Specifications.(a) Each gram of powder contains 8 milligrams (0.8 percent) decoquinate.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.170 of this chapter.
Conditions of use. CalvesAmount.(d) —(1) Feed 22.7 milligrams per 100 pounds of body weight (0.5 milligram per kilogram) per day.
Indications for use.Eimeria bovisE. zuernii.(2) For the prevention of coccidiosis in ruminating and nonruminating calves, including veal calves, caused by and
Limitations.(3) Feed in whole milk at the rate of 22.7 milligrams per 100 pounds body weight daily (0.5 milligram per kilogram) for at least 28 days.
[64 FR 10103, Mar. 2, 1999, as amended at 64 FR 30386, June 8, 1999; 79 FR 28819, May 20, 2014]
Specifications.(a) Each tablet contains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib.
Sponsors.(b) See Nos. 013744, 058198, and 086101 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally as needed, as a single daily dose based on body weight:
(i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in paragraph (d)(2)(i) of this section.
(ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section.
(iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) of this section.
Indications for use.(2) (i) For the control of pain and inflammation associated with osteoarthritis.
(ii) For the control of postoperative pain and inflammation associated with dental surgery.
(iii) For the control of postoperative pain and inflammation associated with orthopedic surgery.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012; 84 FR 39183, Aug. 9, 2019; 86 FR…
Specifications.(a) Each packet contains 10 milligrams (mg) of dexamethasone.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in cattle and horsesAmount.(c) —(1) Administer 5 to 10 mg per animal the first day then 5 mg per day as required by drench or by sprinkling on a small amount of feed.
Indications for use.(2) As supportive therapy following parenteral steroid administration for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.
[79 FR 28819, May 20, 2014]
Specifications.(a)(1) Each bolus is half-scored and contains 10 milligrams of dexamethasone.
Sponsor.(2) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in cattle and horsesAmount.(3) —(i) Administer orally 5 to 10 milligrams on the first day, then 5 milligrams per day as required.
Indications for use.(ii) As supportive therapy following parenteral steroid administration for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.
Specifications.(b)(1) Each tablet contains 0.25 milligram of dexamethasone.
Sponsors.(2) See Nos. 000061 and 061133 in § 510.600(c) of this chapter.
Conditions of use in dogs and catsAmount.(3) —(i) Dogs: Administer orally 0.25 to 1.25 milligrams per day for up to 7 days. Cats: Administer orally 0.125…
Specifications.(a) Each half-scored tablet contains 0.25 milligram of dexamethasone.
Sponsor.(b) See No. 051031 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer by free-choice feeding or crumbled over food 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved.
Indications for use.(2) As supportive therapy in nonspecific dermatosis and inflammatory conditions.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, 2017]
Specifications.(a) Diatrizoate meglumine oral solution is a water soluble radiopaque medium containing 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogs and catsAmount.(c) —(1) Administer orally 0.5 to 1.0 milliliter per pound of body weight by gavage or stomach tube. Administered rectally 0.5 to 1.0 milliliter per pound of body weight diluted with 1 part of the drug to 5 parts of water.
Indications for use.(2) For radiography of the gastrointestinal tract.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985; 79 FR 28820, May 20, 2014]
Specifications.(a) Each capsule contains 50 milligrams (mg) of dichlorophene and 60 mg of toluene, or multiples thereof.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) Nos. 017135 and 023851 for use only as a single dose.
(2) Nos. 000061, 054771, and 069043 for use in a single dose or divided-dosage regimen.
Required statement.(c) Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before administering to weak or debilitated animals.
Conditions of useAmount.(d) —(1) Administer as follows:
(i) Single dose: Administer 100 mg of dicholorophene and 120 mg of toluene per pound of body weight.
(ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for 6 days.
Indications for use.Toxocara canisToxascaris leoninaAncylostoma caninumUncinaria stenocephalaTaenia pisiformis, Dipylidium caninum,Echinococcus granulosus(2) For the removal of ascarids ( and ) and hookworms ( and ); and as an aid in removing tapeworms ( and ) from dogs and cats.
Limitations.(3) Withhold solid foods and milk for at least…
Specifications.(a) Each tablet contains 1 gram of dichlorophene.
Sponsor.(b) See 023851 in § 510.600(c) of this chapter.
Required statement.(c) Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before administering to weak or debilitated animals.
Conditions of use. DogsAmount.(d) —(1) Single dose of 1 tablet (1 gram of dichlorophene) for each 10 pounds of body weight.
Indications for use.Taenia pisiformisDipylidium caninum(2) It is used as an aid in the removal of tapeworms ( and ).
Limitations.(3) Withhold solid foods and milk for at least 12 hours prior to medication and for 4 hours afterward.
[45 FR 10333, Feb. 15, 1980]
Specifications(a) —(1) Each 2-ounce packet contains 2.27 grams (4 percent) dichlorvos.
(2) Each milligram of powder contains 2.27 milligrams (mg) dichlorvos.
Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section and the product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
Related tolerances.(c) See § 556.180 of this chapter.
Conditions of useSwine (adult gilts, sows, and boars)Amount.(d) —(1) —(i) Add powder to the indicated amount of feed and administered shortly after mixing, as follows:
Indications for use.Trichuris suisOesophagostomumAscaris suumAscarops strongylina(ii) For the removal and control of sexually mature (adult), sexually immature and/or 4th stage larvae of the whipworm (), nodular worms ( spp.), large round-worm (), and the mature thick stomach worm () occurring in the lumen of the gastrointestinal tract of pigs, boars, and open or bred gilts and sows.
Limitations.(iii) Do not use this product on animals either simultaneously or within a few days before or after treatment with or exposure to cholinesterase…
Specifications.(a) Each tablet contains 2, 5, 10, or 20 milligrams (mg) dichlorvos.
Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter.
Conditions of use in dogs, puppies, cats, and kittensAmount.(c) —(1) Administer orally at 5 mg dichlorvos per pound of body weight.
Indications for useDogs and puppies:Toxocara canisToxascaris leoninaAncylostoma caninumUncinaria stenocephala(2) —(i) Removal and control of intestinal roundworms ( and ) and hookworms ( and ).
Cats and kittens:Toxocara catiToxascaris leoninaAncylostoma tubaeformeUncinaria stenocephala(ii) Removal and control of intestinal roundworms ( and ) and hookworms ( and ).
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[83 FR 48945, Sept. 28, 2018]
Specifications.(a) Each capsule contains 2.27 milligrams (mg) (4 percent) dichlorvos.
Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer any combination of capsules and/or pellets so that the animal receives a single dose equaling 12 to 15 mg of dichlorvos per pound of body weight.
Indications for use.Toxocara canisToxascaris leoninaAncylostoma caninumUncinaria stenocephalaTrichuris vulpis(2) For removal of and (roundworms), and (hookworms), and (whipworm) residing in the lumen of the gastrointestinal tract.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[83 FR 48945, Sept. 28, 2018]
Specifications.(a) Each milligram (mg) of gel contains 2.27 milligrams (mg) dichlorvos.
Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter.
Conditions of use in horsesAmount.(c) —(1) Administer 20 mg per kilogram of body weight for the removal of bots and ascarids. Repeat administration every 21 to 28 days for the control of bots and ascarids. For the control of bots only, the repeat dosage is 10 milligrams per kilogram of body weight every 21 to 28 days during bot fly season.
Indications for use.Gastrophilus intestinalisG. nasalisParascaris equorum(2) For the removal and control of first, second, and third instar bots ( and ), sexually mature and sexually immature (4th stage) ascarids () in horses and foals.
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[83 FR 48945, Sept. 28, 2018]
Specifications.(a) Each 100 grams (g) of pellets contain 1.56 g diclazuril.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in horsesAmount.(c) —(1) Administer 1 milligram (mg) per kilogram (0.45 mg per pound) of body weight in the daily grain ration for 28 days.
Indications for use.Sarcocystis neurona.(2) For the treatment of equine protozoal myeloencephalitis (EPM) caused by
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[72 FR 20943, Apr. 27, 2007]
Specifications.(a) Each capsule contains dicloxacillin sodium monohydrate equivalent to 50, 100, 200, or 500 milligrams of dicloxacillin.
Sponsor.(b) See No. 054771 in § 510.600 (c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally 5 to 10 milligrams per pound of body weight, three times daily. In severe cases, up to 25 milligrams per pound of body weight three times daily.
Indications for use.(2) For the treatment of pyoderma (pyogenic dermatitis) due to penicillinase-producing staphylococci sensitive to dicloxacillin.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37325, Aug. 18, 1992, as amended at 79 FR 28820, May 20, 2014]
Specifications.(a) Each tablet contains 0.2 milligram (mg) aminopentamide hydrogen sulphate.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogs and catsAmount.(c) —(1) Administer orally every 8 to 12 hours as follows: For animals weighing up to 10 pounds (lbs): 0.1 mg; for animals weighing 11 to 20 lbs: 0.2 mg; for animals weighing 21 to 50 lbs: 0.3 mg; for animals weighing 51 to 100 lbs: 0.4 mg; for animal weighing over 100 lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five times the suggested dosage. Oral administration of tablets may be preceded by subcutaneous or intramuscular use of the injectable form of the drug.
Indications for use.(2) For the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28816, May 20, 2014]
§ 520.620Diethylcarbamazine oral dosage forms.
§ 520.622Diethylcarbamazine citrate oral dosage forms.
Sponsors.(a) (1) [Reserved]
(2) See 054771 in § 510.600(c) of this chapter for use of 100, 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs.
(3) See 061133 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.
(4) [Reserved]
(5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.
(6) See No. 069043 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.
Conditions of useDosage/indications for use.Dirofilaria immitis(b) —(1) (i) Three milligrams per pound of body weight daily for…
Specifications.(a)(1) Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.
Sponsor.(2) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use.Dirofilaria immitisT. canisT. leonina.T. canisT. leoninaT. cati(3) (i) The drug is indicated for use in dogs for the prevention of infection with and and It is also indicated for treatment of ascarid infections of and in dogs and in cats.
(ii) For prevention of heartworm and ascarid infections in dogs, the drug may be added to the daily diet at a dosage rate of 3.0 milligrams per pound of body weight per day or given directly by mouth at the same dosage rate. For treatment of ascarid infections in dogs and cats, the drug is administered at a dosage level of 25 to 50 milligrams per pound of body weight preferably administered immediately after feeding.
Dirofilaria immitisDirofilaria immitis(iii) Older dogs should be proven negative for the presence of infection before administration of the drug. Those with proven infection of should be rendered negative using adulticidal and microfilaricidal drugs before administration of this drug.
(iv) Federal law restricts this drug to use by or on the order of a…
§ 520.622cDiethylcarbamazine citrate chewable tablets.
Specifications.(a) Each chewable tablet contains 30, 45, 60, 120, 150, or 180 milligrams of diethylcarbamazine citrate.
Sponsors.(b) See drug listing nos. in § 510.600(c) of this chapter for identification of sponsors as follows:
(1) [Reserved]
(2) For 054771, use of 60, 120, or 180 milligram tablets as in paragraph (c)(2)(ii) of this section.
(3) For 061690, use of 45 or 150 milligram tablets as in paragraph (c)(2)(iii) of this section.
(4) For 061133, use of 60-, 120-, or 180-milligram tablets as in paragraph (c)(2)(i) of this section.
(5) For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this section.
(6) For 069043, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section.
Conditions of useAmount.(c) —(1) 3 milligrams per pound of body weight per day for prevention of heartworm disease and control of ascarids; 25 to 50 milligrams per pound of body weight as an aid in treatment of ascarid infections.
Indications for use.Dirofilaria immitisToxocara canisToxocara canisToxascaris leonina(2) (i) For prevention of heartworm disease () in dogs; as an aid in control of ascarids () in dogs; as an aid in treatment of ascarid (…
§ 520.623Diethylcarbamazine and oxibendazole chewable tablets.
Specifications.(a) Each tablet contains either 60, 120, or 180 milligrams of diethylcarbamazine citrate with 45, 91, or 136 milligrams of oxibendazole, respectively.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally to dogs at a dosage level of 6.6 milligrams of diethylcarbamazine citrate per kilogram of body weight (3 milligrams per pound of body weight) and 5.0 milligrams of oxibendazole per kilogram of body weight (2.27 milligrams per pound of body weight).
Indications for use.Dirofilaria immitisAncylostoma caninumTrichuris vulpisToxocara canis(2) For prevention of infection with (heartworm disease) and (hookworm infection) and for removal and control of (whipworm infection) and mature and immature stages of intestinal (ascarid infection).
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[50 FR 28768, July 16, 1985, as amended at 53 FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014]
Specifications.(a) Each tablet contains 11.4, 45.4, or 136 milligrams (mg) of difloxacin hydrochloride.
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
(c) [Reserved]
Conditions of useAmount.(d) —(i) Administer 5 to 10 mg per kilogram (2.3 to 4.6 mg per pound) of body weight orally once a day for 2 to 3 days beyond cessation of clinical signs of disease up to a maximum of 30 days.
Indications for use.(ii) For management of diseases in dogs associated with bacteria susceptible to difloxacin.
Limitations.(iii) Federal law prohibits the extra-label use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010]
Specifications.(a) Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) The initial dosage is 0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved.
Indications for use.(2) For the management of obesity.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[72 FR 263, Jan. 4, 2007, as amended at 79 FR 28820, May 20, 2014]
Specifications.(a) Each tablet contains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide.
Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter.
Conditions of use in dogsIndications for use and amount.(c) —(1) Administer orally immediately after feeding as follows:
Toxocara canis, Toxascaris leonina(i) For large roundworms (): 10 mg per pound (/lb) of body weight for 3 to 5 days;
Ancylostoma caninum, Uncinaria stenocephalaTrichuris vulpis(ii) For hookworms () and whipworms (): 10 mg/lb of body weight for 7 days;
Strongyloides canis, Strongyloides stercoralis(iii) For Strongyloides (): 10 mg/lb of body weight for 10 to 12 days;
Dirofilaria immitus(iv) For heartworm microfilariae (): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should follow 6 weeks after therapy for adult worms.
Limitations.(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28820, May 20, 2014, as amended at 83 FR 48945, Sept. 28, 2018]
Specifications.(a) Each tablespoon of powder contains 200 milligrams (mg) dithiazanine iodide.
Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter.
Conditions of use in dogsIndications for use and amount.(c) —(1) Administer orally by mixing in food as follows:
Toxocara canis, Toxascaris leonina(i) For large roundworms (): 10 mg per pound (/lb) of body weight for 3 to 5 days;
Ancylostoma caninum, Uncinaria stenocephalaTrichuris vulpis(ii) For hookworms () and whipworms (): 10 mg/lb of body weight for 7 days;
Strongyloides canis,Strongyloides stercoralis(iii) For Strongyloides ( ): 10 mg/lb of body weight for 10 to 12 days;
Dirofilaria immitus(iv) For heartworm microfilariae (): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should follow 6 weeks after therapy for adult worms.
Limitations.(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28820, May 20, 2014, as amended at 83 FR 48945, Sept. 28, 2018]
§ 520.763cDithiazanine iodide and piperazine citrate suspension.
Specifications.(a) Each milliliter of suspension contains 69 milligrams (mg) dithiazanine iodide and 83 mg piperazine base (as piperazine citrate).
Sponsor.(b) See No. 069043 in § 510.600(c) of this chapter.
Conditions of use in horsesAmount.3/41/4(c) —(1) 1 ounce (30 milliliters) per 100 pounds of body weight for the first 500 pounds; ounce for each 100 pounds thereafter, up to 1,200 pounds; 10 ounces to animals over 1,200 pounds.
Indications for use.Parascaris equorum;Strongylus vulgaris;Oxyuris equi.(2) For control of large roundworms, small strongyles; large strongyles, and pinworms,
Limitations.(3) Administer by drench or mixed with the daily ration as a single dose. Treatment is recommended in spring and fall. In a heavily infested environment, treatment may be repeated every 30 days. Not for use in horses intended for food purposes. Severely debilitated animals should not be wormed except on the advice of a veterinarian. If the drug is for administration by stomach tube, it shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
[47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18,…
Specifications.(a) Each milliliter of gel contains 110 milligrams (mg) domperidone.
Sponsor.(b) See No. 043264 in § 510.600 of this chapter.
Conditions of use in horsesAmount.(c) —(1) Administer 0.5 mg per pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 15 days prior to the expected foaling date. Treatment may be continued for up to 5 days after foaling if mares are not producing adequate milk.
Indications for use.(2) For prevention of fescue toxicosis in periparturient mares.
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[75 FR 67031, Nov. 1, 2010]
Specifications.(a) The drug is in tablet form and contains doxylamine succinate as the active drug ingredient.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of useAmount.(c) —(1) Horses: Administer orally 1 to 2 milligrams (mg) per pound (/lb) of body weight per day divided into 3 or 4 equal doses. Dogs and cats: Administer orally 2 to 3 mg/lb of body weight per day divided into 3 or 4 equal doses.
Indications for use.(2) For use when antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats.
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 2014]
Specifications.(a) Each tablet contains 1.0, 2.5, 5.0, 10, or 20 milligrams (mg) of enalapril maleate.
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally 0.5 to 1.0 mg of enalapril maleate per kilogram of body weight per day.
Indications for use.(2) For the treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28821, May 20, 2014, as amended at 80 FR 34278, June 16, 2015; 84 FR 39183, Aug. 9, 2019]
Specifications.(a) (1) Each tablet contains:
(i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
(ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
(2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.
(3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.
Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) No. 058198 for use of products described in paragraph (a) of this section.
(2) Nos. 017033 and 086117 for use of product described in paragraph (a)(1)(i) of this section.
(3) Nos. 055529 and 086101 for use of product described in paragraph (a)(2) of this section.
Conditions of use in dogs and catsAmount.(c) —(1) Administer orally as a single, daily dose or divided into two equal doses at 12-hour intervals.
Dogs.(i) 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight.
Cats.(ii) 5 mg/kg (2.27 mg/lb) of body weight.
Indications for use.(2) For the management of diseases associated with bacteria susceptible to enrofloxacin.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law…
Specifications.(a) Each tablet contains either 12.5, 25, 50, or 100 milligrams of epsiprantel.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) 2.5 milligrams per pound of body weight.
Indications for use.Dipylidium caninumTaenia pisiformis.(ii) Removal of canine cestodes and
CatsAmount.(2) —(i) 1.25 milligrams per pound of body weight.
Indications for use.D.caninumT.taeniaeformis.(ii) Removal of feline cestodes and
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28821, May 20, 2014; 83 FR 64740, Dec. 18, 2018]
§ 520.82Aminopropazine oral dosage forms.
Specifications.(a) Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogs and catsAmount.(c) —(1) Administer orally at a dosage of 1 to 2 milligrams per pound of body weight, repeated every 12 hours as indicated.
Indications for use.(2) For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28816, May 20, 2014]
Specifications.(a) Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base and neomycin sulfate equivalent to 50 milligrams (mg) of neomycin base.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally at a dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated.
Indications for use.(2) For control of bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28816, May 20, 2014]
Specifications.(a) Each gram of powder contains erythromycin phosphate equivalent to 0.89 gram of erythromycin master standard.
Sponsor.(b) See No. 061133 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.230 of this chapter.
Conditions of use.(d) It is used in drinking water as follows:
Broiler and replacement chickensAmount.(1) —(i) Administer 0.500 gram per gallon for 5 days.
Indications for use.Mycoplasma gallisepticum(ii) As an aid in the control of chronic respiratory disease due to susceptible to erythromycin.
Limitations.(iii) Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Replacement chickens and chicken breedersAmount.(2) —(i) Administer 0.500 gram per gallon for 7 days.
Indications for use.Haemophilus gallinarum(ii) As an aid in the control of infectious coryza due to susceptible to erythromycin.
Limitations.(iii) Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before…
Specifications.(a) Each tablet contains 1 milligram (mg) estriol.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.
Indications for use.(2) For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[76 FR 78150, Dec. 16, 2011]
Specifications.(a) Each tablet contains either 10 milligrams or 50 milligrams of ethylisobutrazine hydrochloride.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally 2 to 5 milligrams per pound of body weight once daily.
Indications for use.(2) As a tranquilizer.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 2014]
Specifications.(a) Each tablet contains 150, 300, or 500 milligrams (mg) of etodolac.
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer 10 to 15 mg per kilogram (4.5 to 6.8 mg per pound) of body weight per day orally.
Indications for use.(2) For the management of pain and inflammation associated with osteoarthritis.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[63 FR 51300, Sept. 25, 1998, as amended at 68 FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, 2010; 79 FR 28821, May 20, 2014]
§ 520.88aAmoxicillin trihydrate film-coated tablets.
Specifications.(a) Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days.
Indications for use.Staphylococcus aureus, StreptococcusEscherichia coli, Proteus mirabilis,S. aureus, StreptococcusP. mirabilis.(ii) Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal tract (bacterial gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of spp., and bacterial dermatitis caused by spp., and
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CatsAmount.(2) —(i) Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days.
Indications for use.S. aureus, StreptococcusE. coli;S. aureus, StreptococcusE. coli,P. mirabilis;E. coli;S. aureus, StreptococcusE. coli,Pasteurella multocida.(ii) Treatment of infections caused by susceptible organisms as follows: upper…
§ 520.88bAmoxicillin trihydrate for oral suspension.
Specifications.(a) When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(1) —(i) —(A) Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days.
Indications for use.Staphylococcus aureus, StreptococcusEscherichia coli,Proteus mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis;S. aureus, StreptococcusP. mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis.(B) Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by spp., and genitourinary tract (cystitis) caused by spp., and gastrointestinal tract (bacterial gastroenteritis) caused by spp., and bacterial dermatitis caused by spp., and and soft tissues (abscesses, lacerations, and wounds) caused by spp., and
Limitations.(C) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CatsAmount.(ii) —(A) Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days.
Indications for…
§ 520.88cAmoxicillin trihydrate oral suspension.
Specifications.(a) Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams (mg) amoxicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.38 of this chapter.
Conditions of use in swineAmount.(d) —(1) Administer 40 mg orally twice a day using a dosing pump. Treat animals for 48 hours after all symptoms have subsided but not beyond 5 days.
Indications for use.Escherichia coli(2) Treatment of baby pigs under 10 pounds for porcine colibacillosis caused by susceptible to amoxicillin.
Limitations.(3) Do not slaughter during treatment or for 15 days after latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, 2014; 85 FR 18118, Apr. 1, 2020]
§ 520.88dAmoxicillin trihydrate soluble powder.
Specifications.(a) Each gram of powder contains amoxicillin trihydrate equivalent to 115.4 milligrams (mg) amoxicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.38 of this chapter.
Conditions of use in preruminating calves including veal calvesAmount.(d) —(1) Administer 400 mg per 100 pounds of body weight twice daily by drench or in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days.
Indications for use.Escherichia coli(2) Treatment of bacterial enteritis when due to susceptible in preruminating calves including veal calves.
Limitations.(3) Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian
[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 6, 1997; 79 FR 28817, May 20, 2014]
Specifications.(a) Each bolus contains amoxicillin trihydrate equivalent to 400 milligrams (mg) amoxicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.38 of this chapter.
Conditions of use in cattleAmount.(d) —(1) Administer 400 mg per 100 pounds of body weight twice daily. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days.
Indications for use.Escherichia coli(2) Treatment of bacterial enteritis when due to susceptible in preruminating calves including veal calves.
Limitations.(3) Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997; 79 FR 28817, May 20, 2014]
Specifications.(a) Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 200, or 400 milligrams (mg) amoxicillin.
Sponsors.(b) See Nos. 051311 and 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer 5 mg per pound of body weight twice daily for 5 to 7 days or 48 hours after all symptoms have subsided.
Indications for use.Staphylococcus aureus, StreptococcusStaphylococcusEscherichia coli;S. aureus, Enterococcus faecalis, E. coli, Proteus mirabilis,Staphylococcus(2) For treatment of bacterial dermatitis due to spp., spp., and and soft tissue infections (abscesses, wounds, lacerations) due to and spp.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 28817, May 20, 2014, as amended at 83 FR 64740, Dec. 18, 2018]
§ 520.88gAmoxicillin trihydrate and clavulanate potassium tablets.
Specifications.(a) Each tablet or chewable tablet contains amoxicillin trihydrate and clavulanate potassium equivalent to 50 milligrams (mg) of amoxicillin and 12.5 mg clavulanic acid, 100 mg of amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter:
(1) No. 054771 for use of tablets and chewable tablets as in paragraph (c) of this section.
(2) Nos. 017033 and 069043 for use of tablets as in paragraph (c) of this section.
Conditions of useDogsAmount.(c) —(1) —(i) 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days.
Indications for use.Staphylococcus aureus,Staphylococcus aureus, StaphylococcusStreptococcusE. coli.(ii) Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamase-producing…
§ 520.88hAmoxicillin trihydrate and clavulanate potassium for oral suspension.
Specifications.(a) When constituted, each milliliter (mL) of suspension contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg clavulanic acid.
Sponsors.(b) See Nos. 017033, 054771, and 069043 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) 6.25 mg/lb (1 mL/10 lb of body weight) twice a day. Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5 to 7 days or for 48 hours after all signs have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days; the maximum duration of treatment should not exceed 30 days.
Indications for use.Staphylococcus aureus,Staphylococcus aureus, StaphylococcusStreptococcusEscherichia coli.(ii) Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamase-producing non-beta-lactamase-producing spp., spp., and Treatment of…
Specifications.(a) Each tablet contains ampicillin trihydrate equivalent to 50 or 100 milligrams of ampicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) 5 milligrams per pound of body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be continued 36 to 48 hours after all symptoms have subsided. If no improvement is seen within 5 days, stop treatment, reevaluate diagnosis, and change therapy.
Indications for use.StreptococcusStaphylococcusEscherichia coli, Proteus mirabilis,PasteurellaStreptococcusStaphylococcusE., coli, P. mirabilis,EnterococcusStaphylococcusStreptococcusEnterococcusE. coli.StaphylococcusStreptococcus(2) Oral treatment of infections caused by susceptible organisms as follows: Upper respiratory infections, tonsillitis, and bronchitis due to spp., spp., and spp., urinary tract infections (cystitis) due to spp., spp., and spp.; gastrointestinal infections due to spp., spp., spp., and ; infections associated with abscesses, lacerations, and wounds caused by spp., and spp.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37321, Aug.…
Specifications.(a) Each capsule contains ampicillin trihydrate equivalent to 125, 250, or 500 milligrams of ampicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of useDogsAmount.(c) —(1) —(i) 5 to 10 milligrams per pound of body weight two or three times daily. In severe or acute conditions, 10 milligrams per pound of body weight, three times daily. Administer 1 to 2 hours prior to feeding.
Indications for use.(ii) Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (tracheobronchitis and tonsillitis); urinary tract infections (cystitis); bacterial gastroenteritis; generalized infections (septicemia) associated with abscesses, lacerations, and wounds; and bacterial dermatitis.
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CatsAmount.(2) —(i) 10 to 30 milligrams per pound of body weight or three times daily. Administer 1 to 2 hours prior to feeding.
Indications for use.(ii) Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory…
Specifications.(a) Each bolus contains ampicillin trihydrate equivalent to 400 milligrams of ampicillin.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.40 of this chapter.
Conditions of use in nonruminating calvesAmount.(d) —(1) 5 milligrams per pound of body weight twice daily not to exceed 4 days.
Indications for use.E. coli.(2) Oral treatment of bacterial enteritis (colibacillosis) caused by
Limitations.(3) Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, 2014. Redesignated and amended at 85 FR 18118, Apr. 1, 2020]
Specifications.(a) Each gram of paste contains 455 milligrams (45.5 percent) febantel.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of use in horsesAmount.(c) —(1) Administer paste orally at 6 milligrams per kilogram (2.73 milligrams per pound) of body weight on the base of the tongue or well mixed into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.
Indications for use.Strongylus vulgaris, S. edentatus,S. equinusParascaris equorumOxyuris equi(2) For removal of large strongyles ( ); ascarids (—sexually mature and immature); pinworms (—adult and 4th stage larva); and various small strongyles in horses, foals, and ponies.
Limitations.(3) Do not use in horses intended for human consumption. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
[79 FR 28821, May 20, 2014, as amended at 86 FR 14818, Mar. 19, 2021]
Specifications.(a) Each ounce of suspension contains 2.75 grams (9.3 percent ounce) febantel.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of use in horsesAmount.(c) —(1) 3 milliliters per 100 pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body weight). Administer by stomach tube or drench, or by mixing well into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.
Indications for use.Parascaris equorumOxyuris equiStrongylus vulgaris, S. edentatus,S. equinus(2) For removal of ascarids (—adult and sexually immature), pinworms (—adult and 4th stage larvae), large strongyles ( ), and various small strongyles in horses, breeding stallions and mares, pregnant mares, foals, and ponies.
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Special considerations.(d) Febantel suspension may be used in combination with trichlorfon oral liquid in accordance with the provisions of §…
Specifications.(a) Each gram of paste contains 34 milligrams of febantel and 3.4 milligrams of praziquantel.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of useAmount(c) —(1) —(i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days.
(ii) Puppies and kittens (less than 6 months of age): 15 milligrams of febantel and 1.5 milligrams of praziquantel per kilogram of body weight (1 gram of paste per 5 pounds body weight) administered by mouth on a full stomach once daily for 3 days.
Indications for use.Ancylostoma caninumUncinaria stenocephalaTrichuris vulpisToxocara canisToxascaris leoninaDipylidium caninumTaenia pisiformis(2) (i) Dogs and puppies: For removal of hookworms ( and ), whipworms (), ascarids ( and ), and tapeworms ( and ).
Ancylostoma tubaeformeToxocara catiDipylidium caninumTaenia taeniaeformis(ii) Cats and kittens: For removal of hookworms (), ascarids () and tapeworms ( and ).
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed…
Specifications.(a) Each scored tablet contains 27.2 milligrams of febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams of febantel for use in dogs, puppies, and cats.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of useAmountDogs and cats.(c) —(1) —(i) Ten milligrams per kilogram body weight. Administer once daily for 3 consecutive days.
Puppies and kittens fewer than 6 months of age.(ii) Fifteen milligrams per kilogram body weight. Administer once daily for 3 consecutive days.
Indications for use.Ancylostoma caninumUncinaria stenocephalaToxocara canisToxascaris leoninaTrichuris vulpis(2) (i) For removal of hookworms ( and ), ascarids ( and ) and whipworms () in dogs and puppies.
Ancylostoma tubaeformeToxocara cati(ii) For removal of hookworms () and ascarids () in cats and kittens.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[56 FR 50655, Oct. 8, 1991, as amended at 79 FR 28821, May 20, 2014. Redesignated at 85 FR 18119, Apr. 1, 2020, as amended at 86 FR 14818, Mar. 19, 2021]
Specifications.(a) Each milliliter of suspension contains 100 milligrams (mg) fenbendazole for use as in paragraphs (e)(1), (2), (3), and (4) of this section; or 200 mg fenbendazole for use as in paragraphs (e)(5) and (6) of this section.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.275 of this chapter.
Special considerations.(d) (1) See § 500.25 of this chapter.
(2) Fenbendazole suspension 10 percent and approved forms of trichlorfon, when used concomitantly for treating the indications provided in paragraph (e) of this section and for treating infections of stomach bot as provided in § 520.2520, have been shown to be compatible and not to interfere with one another.
Conditions of useHorsesAmount.(e) —(1) —(i) Administer orally 5 mg per kilogram (/kg) (2.3 mg per pound (/lb)) for the control of large strongyles, small strongyles, and pinworms; 10 mg/kg for the control of ascarids.
Indications for use.Strongylus edentatus, S. equinus, S. vulgaris, TriodontophorusCyathostomumCylicocyclusCylicostephanusCylicodontophorusOxyuris equiParascaris equorum(ii) For the treatment and control of large strongyles ( species), small…
Specifications.(a) Each gram of granules contains 222 milligrams (mg) fenbendazole.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Special considerations.(c) See § 500.25 of this chapter.
Conditions of useHorsesAmount.(d) —(1) —(i) 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids.
Indications for use.Strongylus edentatus, S. equinus, S. vulgarisOxyuris equiParascaris equorum(ii) For the control of infections of large strongyles (), small strongyles, pinworms (), and ascarids ().
Limitations.(iii) Sprinkle the appropriate amount of drug on a small amount of the usual grain ration. Prepare for each horse individually. Withholding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food.
DogsAmount.(2) —(i) 50 mg/kg daily for 3 consecutive days.
Indications for use.Toxocara canis, Toxascaris leoninaAncylostoma caninum, Uncinaria stenocephalaTrichuris vulpisTaenia pisiformis(ii) For the treatment and control of ascarids (), hookworms (), whipworms (), and tapeworms ().
Limitations.(iii) Mix the appropriate amount of drug with a small amount of the usual food; dry dog…
Specifications.(a) Each gram of paste contains 100 milligrams (mg) fenbendazole (10 percent).
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.275 of this chapter.
Special considerations.(d) See § 500.25 of this chapter.
Conditions of useHorsesIndications for use and amounts.Strongylus edentatus, S. equinus,S. vulgarisOxyuris equi(e) —(1) —(i) (A) For the treatment and control of large strongyles ( ), small strongyles, and pinworms (). For large strongyles, small strongyles, and pinworms, the recommended dose is 5 mg/kg (2.3 mg/lb).
Parascaris equorum(B) For treatment and control of ascarids (). For ascarids, the recommended dose is 10 mg/kg (4.6 mg/lb).
Strongylus vulgaris(C) For treatment and control of hypobiotic (encysted early third-stage), late third-stage, and fourth-stage cyathostome larvae, as well as fourth-stage larvae, the recommended dose is 10 mg/kg (4.6 mg/lb) daily for 5 consecutive days.
Strongylus vulgaris(D) For the control of arteritis caused by fourth-stage larvae of in horses.
(E) Fenbendazole paste 10 percent may be used concomitantly with approved forms of trichlorfon for the indications provided in…
Specifications.(a) Each 2-ounce packet contains 2.27 grams (4 percent) fenbendazole.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.275 of this chapter.
Conditions of use.(d) It is administered to swine as follows:
Amount.(1) 3 milligrams fenbendazole per kilogram body weight per day (1.36 milligrams per pound per day).
Indications for use.Ascaris suumMetastrongylus apriOesophagostomum dentatum, O. quadrispinulatumHyostrongylus rubidusTrichuris suisStephanurus dentatus(2) For removal and control of large roundworms (); lungworms (); nodular worms (); small stomach worms (); whipworms (); and kidneyworms (— mature and immature).
Limitations.(3) Thoroughly mix the contents of the packet(s) with swine ration and administer according to label directions. Feed as sole ration for 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed or water is necessary. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
[49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, Nov. 25, 2009; 83 FR…
Specifications.(a) (1) Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib.
(2) Each tablet contains 57 mg firocoxib.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 000010 and 055529 for use of products described in paragraph (a)(1) as in paragraph (c)(1) of this section; and
(2) Nos. 000010 and 055246 for use of the product described in paragraph (a)(2) as in paragraph (c)(2) of this section.
Conditions of useDogsAmount.(c) —(1) —(i) 5 mg/kg (2.27 mg/lb) body weight. Administer once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. Administer approximately 2 hours before soft tissue or orthopedic surgery.
Indications for use.(ii) For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.
Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
HorsesAmount.(2) —(i) Administer one 57-mg tablet to horses weighing 800 to 1,300 lb once daily for up to 14 days.…
Specifications.(a) Each milligram (mg) of paste contains 0.82 mg firocoxib.
Sponsors.(b) See No. 000010 in § 510.600(c) of this chapter.
Conditions of use in horsesAmount.(c) —(1) 0.1 mg per kilogram (0.045 mg per pound) body weight daily for up to 14 days.
Indications for use.(2) For the control of pain and inflammation associated with osteoarthritis.
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[71 FR 5788, Feb. 3, 2006, as amended at 84 FR 39183, Aug. 9, 2019]
Specifications.(a) Each milliliter (mL) contains 23 milligrams (mg) florfenicol.
Sponsors.(b) See Nos. 000061, 054925, and 058198 in § 510.600(c) of this chapter.
Related tolerances.(c) See § 556.283 of this chapter.
Conditions of use in swineAmount.ad libitum(d) —(1) Administer in drinking water at 400 mg per gallon (100 parts per million (ppm)) for 5 consecutive days.
Indications for use.Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuisStreptococcus suis.(2) For the treatment of swine respiratory disease (SRD) associated with and
Limitations.(3) Do not slaughter within 16 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[67 FR 78357, Dec. 24, 2002, as amended at 72 FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013; 82 FR 12169, Mar. 1, 2017]
Specifications.(a) Each tablet contains 0.0625 milligram of flumethasone.
Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.
Conditions of useAmountDogs:(c) —(1) —(i) Administer orally from 0.0625 to 0.25 milligram daily in divided doses.
Cats:(ii) Administer orally from 0.03125 to 0.125 milligram daily in divided doses.
Indications for useDogs:(2) —(i) It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syndrome, and myositis.
Dogs and cats:(ii) It is used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014]
Specifications.(a) (1) Each 10-gram (g) packet of granules contains flunixin meglumine equivalent to 250 milligrams (mg) of flunixin.
(2) Each 30-g syringe of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin.
Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) No. 000061 for use of products described in paragraph (a).
(2) No. 061133 for use of the product described in paragraph (a)(2).
Conditions of use in horsesAmount.(c) —(1) 0.5 mg per pound of body weight per day for up to 5 days.
Indications for use.(2) For alleviation of inflammation and pain associated with musculoskeletal disorders.
Limitations.(3) Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[76 FR 53051, Aug. 25, 2011, as amended at 79 FR 74020, Dec. 15, 2014; 84 FR 8972, Mar. 13, 2019]
Specifications.(a) Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.
Sponsor.(b) See No. 055246 in § 510.600 of this chapter.
Conditions of use in dogsAmount.(c) —(1) 1 to 2 mg per kilogram body weight once daily.
Indications for use.(2) For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017]
Specifications.(a) (1) Each chewable tablet contains 112.5, 250, 500, 1,000, or 1,400 milligrams (mg) fluralaner.
(2) Each chewable tablet contains 45, 100, 200, 400, or 560 mg fluralaner.
Sponsor.(b) See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.(c) —(1) Administer orally as a single dose with food:
Chewable tablets described in paragraph (a)(1) of this section.Amblyomma americanum(i) Administer every 12 weeks, an appropriate combination of tablets to provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram (kg)) body weight. May be administered every 8 weeks in case of potential exposure to ticks.
Chewable tablets described in paragraph (a)(2) of this section.(ii) Administer monthly, an appropriate combination of tablets to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight.
Indications for useChewable tablets described in paragraph (a)(1) of this section.Ctenocephalides felisIxodes scapularisDermacentor variabilisRhipicephalus sanguineusHaemaphysalis longicornisAmblyomma americanum(2) —(i) Kills adult fleas; for the treatment and prevention of flea infestations (), and the treatment and control of tick infestations (…
