Code of Federal Regulations · Section
§ 341.12 — Antihistamine Active Ingredients
21 C.F.R. § 341.12
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The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient:
(a) Brompheniramine maleate.
(b) Chlorcyclizine hydrochloride.
(c) Chlorpheniramine maleate.
(d) Dexbrompheniramine maleate.
(e) Dexchlorpheniramine maleate.
(f) Diphenhydramine citrate.
(g) Diphenhydramine hydrochloride.
(h) Doxylamine succinate.
(i) Phenindamine tartrate.
(j) Pheniramine maleate.
(k) Pyrilamine maleate.
(l) Thonzylamine hydrochloride.
(m) Triprolidine hydrochloride.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321