Title 21

PART 341

Part 341 - Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-the-counter Human Use

PART 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority:21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Editorial Note:Nomenclature changes to part 341 appear at 69 FR 13717, Mar. 24, 2004.

• Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

21:5.0.1.1.19.1	SUBPART A	Subpart A - General Provisions
21:5.0.1.1.19.1.1.1	SECTION 341.1	341.1 Scope.
21:5.0.1.1.19.1.1.2	SECTION 341.3	341.3 Definitions.
21:5.0.1.1.19.2	SUBPART B	Subpart B - Active Ingredients
21:5.0.1.1.19.2.1.1	SECTION 341.12	341.12 Antihistamine active ingredients.
21:5.0.1.1.19.2.1.2	SECTION 341.14	341.14 Antitussive active ingredients.
21:5.0.1.1.19.2.1.3	SECTION 341.16	341.16 Bronchodilator active ingredients.
21:5.0.1.1.19.2.1.4	SECTION 341.18	341.18 Expectorant active ingredient.
21:5.0.1.1.19.2.1.5	SECTION 341.20	341.20 Nasal decongestant active ingredients.
21:5.0.1.1.19.2.1.6	SECTION 341.40	341.40 Permitted combinations of active ingredients.
21:5.0.1.1.19.3	SUBPART C	Subpart C - Labeling
21:5.0.1.1.19.3.1.1	SECTION 341.70	341.70 Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product).
21:5.0.1.1.19.3.1.2	SECTION 341.72	341.72 Labeling of antihistamine drug products.
21:5.0.1.1.19.3.1.3	SECTION 341.74	341.74 Labeling of antitussive drug products.
21:5.0.1.1.19.3.1.4	SECTION 341.76	341.76 Labeling of bronchodilator drug products.
21:5.0.1.1.19.3.1.5	SECTION 341.78	341.78 Labeling of expectorant drug products.
21:5.0.1.1.19.3.1.6	SECTION 341.80	341.80 Labeling of nasal decongestant drug products.
21:5.0.1.1.19.3.1.7	SECTION 341.85	341.85 Labeling of permitted combinations of active ingredients.
21:5.0.1.1.19.3.1.8	SECTION 341.90	341.90 Professional labeling.

---