21 C.F.R. § 336.80   Professional labeling.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 336—ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart C—Labeling

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§ 336.80   Professional labeling.

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.”

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