§336.80. Professional labeling.
21 C.F.R. § 336.80
The labeling provided to health professionals (but not to the general public) may contain the following additional indications.
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.”
For products containing meclizine hydrochloride identified in § 336.10(d). “For the treatment of vertigo.”
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 52 FR 15892, Apr. 30, 1987, unless otherwise noted.