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21 C.F.R. § 341.20   Nasal decongestant active ingredients.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients

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§ 341.20   Nasal decongestant active ingredients.

Link to an amendment published at 71 FR 43362, Aug. 1, 2006.

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.

(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]

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