21 C.F.R. § 341.14 : Food and Drugs — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES — DRUGS FOR HUMAN USE — COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE — ACTIVE INGREDIENTS — Antitussive active ingredients

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.

21 C.F.R. § 341.14

52 FR 30055, 8/12/1987, as amended at 59 FR 29174, 6/3/1994; 67 FR 4907, 2/1/2002