CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR341.12]

TITLE 21--FOOD AND DRUGS

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

Sec. 341.12 Antihistamine active ingredients.

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]