GroundRules
21 CFR 336.80: Professional labeling.
Where this section sits in the code
- 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 C—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). “For the treatment of vertigo of motion sickness.”
(b) For products containing meclizine hydrochloride identified in § 336.10(d). “For the treatment of vertigo.”
Collected 2026-08-27T02:24:47Z. Source file · JSON