21 CFR Part 336 — Antiemetic Drug Products for Over-the-Counter Human Use

PART 336—ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 52 FR 15892, Apr. 30, 1987, unless otherwise noted. Subpart A—General Provisions § 336.1 Scope. (a) An over-the-counter antiemetic drug product in a form suitable for oral 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. § 336.3 Definition. As used in this part: Antiemetic. Subpart B—Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in § 336.50(d): (a) Cyclizine hydrochloride. (b) Dimenhydrinate. (c) Diphenhydramine hydrochloride. (d) Meclizine hydrochloride. Subpart C—Labeling § 336.50 Labeling of antiemetic drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (1) For products containing any ingredient identified in § 336.10 When labeled for use in adults and for those products that can be and are labeled for use in children under 12 years of age. (ii) For those products that can be and are labeled only for children under 12 years of age. (2) For products containing cyclizine hydrochloride identified in § 336.10(a). (3) For products containing dimenhydrinate identified in § 336.10(b). (4) For products containing diphenhydramine hydrochloride identified in § 336.10(c). (5) For products containing meclizine hydrochloride identified in § 336.10(d). (6) For products containing cyclizine hydrochloride identified in § 336.10(a) or meclizine hydrochloride identified in § 330.10(d). (7) For products containing dimenhydrinate identified in § 336.10(b) or diphenhydramine hydrochloride identified in § 336.10(c). (8) For products containing diphenhydramine hydrochloride identified in § 336.10(c). 1 1 (d) Directions. (1) For products containing cyclizine hydrochloride identified in § 336.10(a). (2) For products containing dimenhydrinate identified in § 336.10(b). (3) For products containing diphenhydramine hydrochloride identified in § 336.10(c). (4) For products containing meclizine hydrochloride identified in § 336.10(d). (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. [52 FR 15892, Apr. 30, 1987, as amended at 53 FR 35809, Sept. 15, 1988; 59 FR 16982, Apr. 11, 1994; 67 FR 72559, Dec. 6, 2003] § 336.80 Professional labeling. The labeling provided to health professionals (but not to the general public) may contain the following additional indications. (a) For products containing cyclizine hydrochloride, dimenhydrinate, and diphenhydramine hydrochloride identified in § 336.10 (a), (b), and (c). (b) For products containing meclizine hydrochloride identified in § 336.10(d).

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