Code of Federal Regulations · Section
§ 336.80 — Professional Labeling
21 C.F.R. § 336.80
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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.”
Authorizing Statute
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Definitions; generally21 U.S.C. § 321