• 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 Oct 01, 2021.

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]
[CITE: 21CFR341.20]



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. 341.20 Nasal decongestant active ingredients.

The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient:

(a) Oral nasal decongestants. (1) Phenylephrine hydrochloride.

(2) Pseudoephedrine hydrochloride.

(3) Pseudoephedrine sulfate.

(4) Phenylephrine bitartrate in an effervescent dosage form.

(b) Topical nasal decongestants. (1) Levmetamfetamine.

(2) Ephedrine.

(3) Ephedrine hydrochloride.

(4) Ephedrine sulfate.

(5) [Reserved]

(6) Naphazoline hydrochloride.

(7) Oxymetazoline hydrochloride.

(8) Phenylephrine hydrochloride.

(9) Propylhexedrine.

(10) Xylometazoline hydrochloride.

[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, 2006]

-
-