CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR336]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 336 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart B - Active Ingredients

Sec. 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.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 52 FR 15892, Apr. 30, 1987, unless otherwise noted.