Title 21 CFR reference

(a) An over-the-counter cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. [51 FR 35339, Oct. 2, 1986]

The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient: (a) Brompheniramine maleate. (b) Chlorcyclizine hydrochloride. (c) Chlorpheniramine maleate. (d) Dexbrompheniramine maleate. (e) Dexchlorpheniramine maleate. (f) Diphenhydramine citrate. (g) Diphenhydramine hydrochloride. (h) Doxylamine succinate. (i) Phenindamine tartrate. (j) Pheniramine maleate. (k) Pyrilamine maleate. (l) Thonzylamine hydrochloride. (m) Triprolidine hydrochloride. [57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994]

The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in § 341.74(d): Oral antitussives.(a) (1) Chlophedianol hydrochloride. Codeine ingredients.(2) The following ingredients may be used only in combination in accordance with § 290.2 and 21 CFR 1308.15(c). (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3) Dextromethorphan. (4) Dextromethorphan hydrobromide. (5) Diphenhydramine citrate. (6) Diphenhydramine hydrochloride. Topical antitussives.(b) (1) Camphor. (2) Menthol. [52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002]

The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient: (a) Ephedrine. (b) Ephedrine hydrochloride. (c) Ephedrine sulfate. (d) Epinephrine. (e) Epinephrine bitartrate. (f) Racephedrine hydrochloride. (g) Racepinephrine hydrochloride. [51 FR 35339, Oct. 2, 1986]

The active ingredient of the product is guaifenesin when used within the dosage limits established in § 341.78(d). [54 FR 8509, Feb. 28, 1989]

The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient: Oral nasal decongestants.(a) (1) Phenylephrine hydrochloride. (2) Pseudoephedrine hydrochloride. (3) Pseudoephedrine sulfate. (4) Phenylephrine bitartrate in an effervescent dosage form. Topical nasal decongestants.(b) (1) Levmetamfetamine. (2) Ephedrine. (3) Ephedrine hydrochloride. (4) Ephedrine sulfate. (5) [Reserved] (6) Naphazoline hydrochloride. (7) Oxymetazoline hydrochloride. (8) Phenylephrine hydrochloride. (9) Propylhexedrine. (10) Xylometazoline hydrochloride. [59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, 2006]

As used in this part: Bronchodilator drug.(a) A drug used to overcome spasms that cause narrowing of the bronchial air tubes, such as in the symptomatic treatment of the wheezing and shortness of breath of asthma. Oral antitussive drug.(b) A drug that either is taken by mouth or is dissolved in the mouth in the form of a lozenge and acts systemically to relieve cough. Topical antitussive drug.(c) A drug that relieves cough when inhaled after being applied topically to the throat or chest in the form of an ointment or from a steam vaporizer, or when dissolved in the mouth in the form of a lozenge for a local effect. Expectorant drug.(d) A drug taken orally to promote or facilitate the removal of secretions from the respiratory airways. Antihistamine drug.(e) A drug used for the relief of the symptoms of hay fever and upper respiratory allergies (allergic rhinitis). Oral nasal decongestant drug.(f) A drug that is taken by mouth and acts systemically to reduce nasal congestion caused by acute or chronic rhinitis. Topical nasal decongestant drug.(g) A drug that when applied topically inside the nose, in the form of drops, jellies, or sprays, or when inhaled intranasally reduces…

The following combinations are permitted provided each active ingredient is present within the dosage limits established in parts 341, 343, and 356 of this chapter and the product is labeled in accordance with §§ 341.70 or 341.85: (a) Any single antihistamine active ingredient identified in § 341.12 may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (b) Any single antihistamine active ingredient identified in § 341.12 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85. (c) Any single antihistamine active ingredient identified in § 341.12 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or…

The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. For products containing diphenhydramine citrate and diphenhydramine hydrochloride identified in § 341.14(a)(5) and (a)(6).(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antihistamine/cough suppressant” or “antihistamine/antitussive (cough suppressant).” The indications shall be combined from §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 341.72(c)(1), (c)(2), (c)(4), and (c)(6) and 341.74(c)(1), (c)(2), (c)(3), and (c)(4). Alternatively, all of the warnings in § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable. For products containing menthol identified in §§ 341.14(b)(2) and 356.12(f) of this chapter.1(b) The product contains 5 to 10 milligrams menthol. The labeling of the product…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antihistamine.” Indications.(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) “Temporarily” (select one of the following: “relieves,” “alleviates,” “decreases,” “reduces,” or “dries”) “runny nose and” (select one of the following: “relieves,” “alleviates,” “decreases,” or “reduces”) “sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever” (which may be followed by one or both of the following: “or other…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “cough suppressant” or an “antitussive (cough suppressant).” Indications.(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) “Temporarily” (select one of the following: “alleviates,” “calms,” “controls,” “decreases,” “quiets,” “reduces,” “relieves,” or “suppresses”) “cough due to” (select one of the following: “minor bronchial irritation” or “minor throat and bronchial irritation”) (select one of the following: “as may occur with,” “associated with,” or “occurring with”) (select one of the following: “A…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “bronchodilator.” Indication.1(b) The labeling of the product states the following under the heading “Use”: “for temporary relief of mild symptoms of intermittent asthma: [bullet] wheezing [bullet] tightness of chest [bullet] shortness of breath”. Other truthful and nonmisleading statements, describing only the indication for use that has been established and listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act relating to misbranding and the prohibition in section 301(d) of the Federal Food, Drug, and Cosmetic Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. Warnings.(c) The labeling of the product contains the following warnings under the heading “Warnings”: (1) The following statements shall appear after the subheading “Do not use” [in bold type]: (i) “[Bullet] unless a doctor said you…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “expectorant.” Indications.(b) The labeling of the product states, under the heading “Indications,” the following: “Helps loosen phlegm (mucus) and thin bronchial secretions to” (select one or more of the following: “rid the bronchial passageways of bothersome mucus,” “drain bronchial tubes,” and “make coughs more productive”). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. Warnings.(c) The labeling of the product contains the following warnings, under the heading “Warnings”: (1) “A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “nasal decongestant.” Indications.(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section, as appropriate, and may contain any additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraphs (b)(1) and (b)(2) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) (Select one of the following: “For the temporary relief of nasal congestion” or “Temporarily relieves nasal congestion”) (which may be followed by any of the following in paragraphs (b)(1) (i), (ii), and (iii) of this section): (i) “due to”…

The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Statement of identity.(a) For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. If there is no established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph (a). For permitted combinations identified in § 341.40(a), (c), (f), (g), (l), (m), (n), (o), (q), and (r) containing an analgesic-antipyretic active ingredient.(1) The analgesic-antipyretic component of the product shall be identified as a “pain reliever” or “analgesic (pain reliever).” If the product is also labeled to…

The labeling of the product provided to health professionals (but not to the general public) may contain the following additional dosage information for products containing the active ingredients identified below: For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16 (a), (b), (c), and (f).(a) Children 6 to under 12 years of age: oral dosage is 6.25 to 12.5 milligrams every 4 hours, not to exceed 75 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 0.3 to 0.5 milligram per kilogram of body weight every 4 hours, not to exceed 2 milligrams per kilogram of body weight in 24 hours. For products containing chlophedianol hydrochloride identified in 341.14(a)(1).(b) Children 2 to under 6 years of age: oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours. For products containing codeine ingredients identified in § 341.14(a)(2).(c) (1) Children 2 to under 6 years of age: Oral dosage is 1 milligram per kilogram body weight per day administered in four equal divided doses. The average body weight for each age may also be used to determine dosage as…