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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 341.16: Bronchodilator active ingredients.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER D—DRUGS FOR HUMAN USE
  4. PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
  5. Subpart B—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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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