[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341.20]

[Page 237-238]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 341_COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS 
 
                      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.

[[Page 238]]

    (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]