Title 21 CFR reference

The warning and caution statements suggested in subparts B and C of this part, for inclusion in the label or labeling of drugs and devices subject to section 502(d) and (f)(2) and other relevant provisions of the Federal Food, Drug, and Cosmetic Act are issued for the purpose of assisting industry in preparing proper labeling for these articles for over-the-counter sale and in meeting the legal requirements of the act that the label or labeling of drugs and devices bear adequate warnings, in such manner and form as are necessary for the protection of users. Only section 502(d) of the act requires use of the specific language included in these suggested warning and caution statements. These suggested warning or caution statements are illustrative of those that may be necessary or desirable. It is the responsibility of the manufacturer, packer, shipper, or distributor in interstate commerce to see that such statements are adequate for compliance with the provisions of the law. Omission of any article from this suggested list does not relieve drugs and devices subject to provisions of the act from bearing adequate warning or caution statements where such statements are necessary or…

Necessary warning statements should appear in the labeling prominently and conspicuously as compared to other words, statements, designs, and devices, and in bold type on clearly contrasting background, in order to comply with the provisions of section 502(c) and (f)(2) of the act. The warning statements should be placed in the labeling in juxtaposition with the directions for use and, in any case, should appear on the label when there is sufficient label space in addition to mandatory label information.

act(a) As used in this part, the term means the Federal Food, Drug, and Cosmetic Act. drugsdevices(b) The terms and are defined in section 201(g) and (k) of the act. (c) Official compendia are defined in section 201(j) of the act.

ACETANILID. ACETOPHENETIDIN CONTAINING PREPARATIONS. (See § 201.309 of this chapter.) ANESTHETICS FOR EXTERNAL USE (LOCAL ANESTHETICS). (See also § 310.201(a)(19) and (23) of this chapter.) ANTIHISTAMINICS FOR EXTERNAL USE (EXCEPT PREPARATIONS FOR OPHTHALMIC USE). ANTIHISTAMINICS, ORAL. (See also § 310.201(a)(4) and (a)(24) of this chapter.) ANTIPYRINE. ANTISEPTICS FOR EXTERNAL USE. ARSENIC PREPARATIONS. BELLADONNA PREPARATIONS AND PREPARATIONS OF ITS ALKALOIDS (ATROPINE, HYOSCYAMINE, AND SCOPOLAMINE (HYOSCINE); HYOSCYAMUS, STRAMONIUM, THEIR DERIVATIVES, AND RELATED DRUG PREPARATIONS. BORIC ACID (POWDERED, CRYSTALLINE, OR GRANULAR). BROMIDES. CARBOLIC ACID (PHENOL) PREPARATIONS (MORE THAN 0.5 PERCENT) FOR EXTERNAL USE. CATHARTICS AND LAXATIVES—IRRITANTS AND OTHER PERISTALTIC STIMULANTS. CHLORATES: MOUTH WASH OR GARGLE. COBALT PREPARATIONS (See also § 250.106 of this chapter.) “COUGH-DUE-TO-COLD” PREPARATIONS. (See also § 310.201(a)(20) of this chapter.) COUNTERIRRITANTS AND RUBEFACIENTS. CREOSOTE, CRESOLS, GUAIACOL, AND SIMILAR SUBSTANCES IN PREPARATIONS FOR EXTERNAL USE. CREOSOTE, CRESOLS, GUAIACOL, AND SIMILAR SUBSTANCES IN DOUCHE PREPARATIONS. DENTURE…

pACETAMINOPHEN (N-ACETYL--AMINOPHENOL) (See § 310.201(a)(1) of this chapter.) ALCOHOL RUBBING COMPOUND. (See 26 CFR 182.855(a)(5); The National Formulary, Tenth Edition 1955, pp. 27-28; and section 502(g) of the act). ANTIHISTAMINICS, ORAL (PHENYLTOLOXAMINE DIHYDROGEN CITRATE AND CHLOROTHEN CITRATE PREPARATIONS). (See § 310.201(a)(4) and (a)(24) of this chapter.) DICYCLOMINE HYDROCHLORIDE WITH AN ANTACID. (See § 310.201(a)(8) of this chapter.) DIPHEMANIL METHYLSULFATE FOR EXTERNAL USE. (See § 310.201(a)(22) of this chapter.) DRUGS IN DISPENSERS PRESSURIZED BY GASEOUS PROPELLANTS. (See also § 310.201(a) (11) and (18) of this chapter.) DYCLONINE HYDROCHLORIDE. (See § 310.201(a)(23) of this chapter.) HEXADENOL. (See § 310.201(a)(11) of this chapter.) IPECAC SYRUP IN ONE-FLUID OUNCE CONTAINERS FOR EMERGENCY TREATMENT OF POISONING, TO INDUCE VOMITING. (See § 201.308 of this chapter.) ISOAMYLHYRDOCUPREINE AND ZOLAMINE HYDROCHLORIDE RECTAL PREPARATIONS FOR EXTERNAL USE (See § 310.201(a)(3) of this chapter.) NEOMYCIN SULFATE WITH A VASOCONSTRICTOR, IN NASAL PREPARATIONS (SPRAY OR DROPS). PRAMOXINE HYDROCHLORIDE FOR EXTERNAL USE. (See § 310.201(a)(19) of this chapter.) SODIUM…

Drugs exempted from prescription-dispensing requirements under section 503(b)(1)(C) of the act are subject to the labeling requirements prescribed in § 310.201(a) of this chapter. Although, for convenience, warning and caution statements for a number of the drugs named in § 310.201 of this chapter (cross-referenced in the text of this part) are included in subpart B of this part, the inclusion of such drugs in §§ 369.20 or 369.21 in no way affects the requirements for compliance with § 310.201(a) of this chapter, or the provisions of an effective application pursuant to section 505(b) of the act. [85 FR 72907, Nov. 16, 2020]

The warning and caution statements included in subpart B of this part in no way affect any warning statement suggested for such drugs or devices by any statement of policy or interpretation in subchapter C of this chapter. [39 FR 11745, Mar. 29, 1974, as amended at 40 FR 13496, Mar. 27, 1975]

Any drug included in the official compendia defined by the act shall bear such warning or caution statement as may be required by such compendia, and no statement in subpart B or subpart C of this part is intended to alter, modify, or permit the omission of any such statement required by such compendia.

The mention in any warning or caution statement included in subparts A, B, and C of this part, of a disease condition does not imply a finding on the part of the Food and Drug Administration that any drug or device is efficacious in such condition; nor is any drug or device bearing labeling referring to such disease condition precluded from regulatory action under the applicable provisions of the act if such claim is considered to be misbranding.

Section 369.20 includes under certain items, but not all medicines, the statement: “Keep this and all medicines out of children's reach. In case of overdose, get medical help or contact a Poison Control Center right away,” or “Keep out of reach of children.” However, in view of the possibility of accidental ingestion of drugs, it is not only suggested but is recommended that one of these statements be used on the label of all drug products. [64 FR 13296, Mar. 17, 1999]