StacksVerified U.S. regulatory reference

21 CFR §336.80

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The labeling provided to health professionals (but not to the general public) may contain the following additional indications.
  1. (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.”
  2. (b)For products containing meclizine hydrochloride identified in § 336.10(d). “For the treatment of vertigo.”