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United States • Title 21 CFR • Part 336
This part establishes the conditions under which over-the-counter (OTC) antiemetic drug products are generally recognized as safe and effective and not misbranded. It specifies the scope, defines antiemetics, lists approved active ingredients, and details the required labeling for these products, including statements of identity, indications, warnings, and directions for use. Professional labeling for health professionals is also addressed.
(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.
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.
As used in this part: Antiemetic. An agent that prevents or treats nausea and vomiting.
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antiemetic.” Indications.(b) The labeling of the product states the following under the heading “Indications,” “For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.” 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), 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:” For products containing any ingredient identified in § 336.10When labeled for use in adults and for those products that can be and are labeled for use in children under 12 years of age.(1) —(i) “Do not take this product, unless directed by a doctor, if you have a…
The labeling provided to health professionals (but not to the general public) may contain the following additional indications. For products containing cyclizine hydrochloride, dimenhydrinate, and diphenhydramine hydrochloride identified in § 336.10 (a), (b), and (c).(a) “For the treatment of vertigo of motion sickness.” For products containing meclizine hydrochloride identified in § 336.10(d).(b) “For the treatment of vertigo.”
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