21 CFR 341.12 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 370-499) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 370-499) — Drugs For Human Use (Subpart A To Parts 370-499) — Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use (§ 341.1 To § 341.90) — Active Ingredients (§ 341.12 To § 341.40) — 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.