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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jul 20, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR341.16]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 341 -- COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart B - Active Ingredients

Sec. 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]

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