Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
§ 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). “For the treatment of vertigo of motion sickness.”

(b) For products containing meclizine hydrochloride identified in § 336.10(d). “For the treatment of vertigo.”

source: 52 FR 15892, Apr. 30, 1987, unless otherwise noted.
cite as: 21 CFR 336.80