§ 341.14 - Antitussive active ingredients.

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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. (1) 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. (1) Camphor.

Menthol.