21 C.F.R. Subpart B—Active Ingredients
Title 21 - Food and Drugs
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] The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in §341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride. (2) Codeine ingredients. The following ingredients may be used only in combination in accordance with §§290.2 and 21 CFR 1308.15(c). (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3) Dextromethorphan. (4) Dextromethorphan hydrobromide. (5) Diphenhydramine citrate. (6) Diphenhydramine hydrochloride. (b) Topical antitussives. (1) Camphor. (2) Menthol. [52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002] The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient: (a) Ephedrine. (b) Ephedrine hydrochloride. (c) Ephedrine sulfate. (d) Epinephrine. (e) Epinephrine bitartrate. (f) Racephedrine hydrochloride. (g) Racepinephrine hydrochloride. [51 FR 35339, Oct. 2, 1986] The active ingredient of the product is guaifenesin when used within the dosage limits established in §341.78(d). [54 FR 8509, Feb. 28, 1989]
Link to an amendment published at 71 FR 43362, Aug. 1, 2006. The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient: (a) Oral nasal decongestants. (1) Phenylephrine hydrochloride. (2) Pseudoephedrine hydrochloride. (3) Pseudoephedrine sulfate. (b) Topical nasal decongestants. (1) Levmetamfetamine. (2) Ephedrine. (3) Ephedrine hydrochloride. (4) Ephedrine sulfate. (5) [Reserved] (6) Naphazoline hydrochloride. (7) Oxymetazoline hydrochloride. (8) Phenylephrine hydrochloride. (9) Propylhexedrine. (10) Xylometazoline hydrochloride. [59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998]
Title 21: Food and Drugs
PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 341.12 Antihistamine active ingredients.
§ 341.14 Antitussive active ingredients.
§ 341.16 Bronchodilator active ingredients.
§ 341.18 Expectorant active ingredient.
§ 341.20 Nasal decongestant active ingredients.
