---
kind: "section"
citation: "21 C.F.R. § 341.12"
title: "21"
number: "341.12"
heading: "Antihistamine active ingredients."
url: "https://uscodex.org/cfr/21/341.12"
---

# §341.12. 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.**

## Notes

### Amendments

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

### Authority

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

### Amendments

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