§341.14. Antitussive active ingredients.
21 C.F.R. § 341.14
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):
Oral antitussives.
Chlophedianol hydrochloride.
Codeine ingredients. The following ingredients may be used only in combination in accordance with § 290.2 and 21 CFR 1308.15(c).
Codeine.
Codeine phosphate.
Codeine sulfate.
Dextromethorphan.
Dextromethorphan hydrobromide.
Diphenhydramine citrate.
Diphenhydramine hydrochloride.
Topical antitussives.
Camphor.
Menthol.
Notes, amendments, and revision history
Amendments
[52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002]
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Amendments
[52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002]