§341.12. Antihistamine active ingredients.

21 C.F.R. § 341.12

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.

Notes, amendments, and revision history

[57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994]

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

[57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994]