Regulation Text
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.
(b) Topical nasal decongestants.
(1) Phenylephrine hydrochloride.
(2) Pseudoephedrine hydrochloride.
(3) Pseudoephedrine sulfate.
(4) Phenylephrine bitartrate in an effervescent dosage form.
(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.
Authority
21 U.S.C. 321,351,352,353,355,360,371.