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]