21 CFR 336.80
§ 336.80 Professional labeling.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 336.80, § 336.80 Professional labeling, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86551
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Full text
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.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.