21 CFR § 341.16 - Bronchodilator active ingredients.

---
identifier: "/us/cfr/t21/s341.16"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 341.16 - Bronchodilator active ingredients."
title_number: 21
title_name: "Food and Drugs"
section_number: "341.16"
section_name: "Bronchodilator active ingredients."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "341"
part_name: "COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
cfr_part: "341"
---


# 341.16 Bronchodilator active ingredients.

The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient:

(a) Ephedrine.

(b) Ephedrine hydrochloride.

(c) Ephedrine sulfate.

(d) Epinephrine.

(e) Epinephrine bitartrate.

(f) Racephedrine hydrochloride.

(g) Racepinephrine hydrochloride.

[51 FR 35339, Oct. 2, 1986]