21 C.F.R. § 336.80
Professional labeling.
Cite as 21 C.F.R. § 336.80 (2026)
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.”
- Cross-references to the CFR
- 336.10