21 C.F.R. § 336.80

Current through October 31, 2024
Section 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."

21 C.F.R. §336.80