C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart B—Active Ingredients

21 C.F.R. § 341.12

Antihistamine active ingredients

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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.

[57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994]
Notes of Decisions
Cited in 1 case, 2008–2008 · leading case: Carter v. Novartis Consum. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008).
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Carter v. Novartis Consum. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008). “See 21 C.F.R. § 341.12 (permissible active ingredients in antihistamines); 21 C.”
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