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]