• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2016.

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

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2016]
[CITE: 21CFR341.14]



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. 341.14 Antitussive active ingredients.

The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in 341.74(d):

(a) Oral antitussives. (1) Chlophedianol hydrochloride.

(2) Codeine ingredients. The following ingredients may be used only in combination in accordance with 290.2 and 21 CFR 1308.15(c).

(i) Codeine.

(ii) Codeine phosphate.

(iii) Codeine sulfate.

(3) Dextromethorphan.

(4) Dextromethorphan hydrobromide.

(5) Diphenhydramine citrate.

(6) Diphenhydramine hydrochloride.

(b) Topical antitussives. (1) Camphor.

(2) Menthol.

-
-