236 Subpart A—General Provisions Subpart B—Active Ingredients
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§ 341.1 21 CFR Ch. I (4–1–01 Edition) 341.78 Labeling of expectorant drug prod- (g) Topical nasal decongestant drug. A ucts. drug that when applied topically inside 341.80 Labeling of nasal decongestant drug the nose, in the form of drops, jellies, products. or sprays, or when inhaled intranasally 341.90 Professional labeling. reduces nasal congestion caused by AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, acute or chronic rhinitis. 360, 371. (h) Calibrated dropper. A dropper cali- brated such that the volume error in- Subpart A—General Provisions curred in measuring any liquid does not exceed 15 percent under normal use § 341.1 Scope. conditions. (a) An over-the-counter cold, cough, [51 FR 35339, Oct. 2, 1986, as amended at 54 FR allergy, bronchodilator, or anti- 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 asthmatic drug product in a form suit- FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, able for oral, inhalant, or topical ad- 1994] ministration is generally recognized as safe and effective and is not mis- Subpart B—Active Ingredients branded if it meets each of the condi- tions in this part and each of the gen- § 341.12 Antihistamine active ingredi- eral conditions established in § 330.1. ents. (b) References in this part to regu- The active ingredient of the product latory sections of the Code of Federal consists of any of the following when Regulations are to chapter I of title 21 used within the dosage limits estab- unless otherwise noted. lished for each ingredient: [51 FR 35339, Oct. 2, 1986] (a) Brompheniramine maleate. (b) Chlorcyclizine hydrochloride. § 341.3 Definitions. (c) Chlorpheniramine maleate. As used in this part: (d) Dexbrompheniramine maleate. (a) Bronchodilator drug. A drug used (e) Dexchlorpheniramine maleate. to overcome spasms that cause nar- (f) Diphenhydramine citrate. rowing of the bronchial air tubes, such (g) Diphenhydramine hydrochloride. as in the symptomatic treatment of (h) Doxylamine succinate. the wheezing and shortness of breath of (i) Phenindamine tartrate. asthma. (j) Pheniramine maleate. (b) Oral antitussive drug. A drug that (k) Pyrilamine maleate. either is taken by mouth or is dis- (l) Thonzylamine hydrochloride. solved in the mouth in the form of a (m) Triprolidine hydrochloride. lozenge and acts systemically to re- [57 FR 58374, Dec. 9, 1992, as amended at 59 lieve cough. FR 4218, Jan. 28, 1994] (c) Topical antitussive drug. A drug that relieves cough when inhaled after § 341.14 Antitussive active ingredients. being applied topically to the throat or The active ingredients of the product chest in the form of an ointment or consist of any of the following when from a steam vaporizer, or when dis- used within the dosage limits and in solved in the mouth in the form of a the dosage forms established for each lozenge for a local effect. ingredient in § 341.74(d): (d) Expectorant drug. A drug taken (a) Oral antitussives. (1) Chlophedianol orally to promote or facilitate the re- hydrochloride. moval of secretions from the res- (2) Codeine ingredients. The following piratory airways. ingredients may be used only in com- (e) Antihistamine drug. A drug used bination in accordance with §§ 329.20(a) for the relief of the symptoms of hay and 341.40 and 21 CFR 1308.15(c). fever and upper respiratory allergies (i) Codeine. (allergic rhinitis). (ii) Codeine phosphate. (f) Oral nasal decongestant drug. A (iii) Codeine sulfate. drug that is taken by mouth and acts (3) Dextromethorphan. systemically to reduce nasal conges- (4) Dextromethorphan hydrobromide. tion caused by acute or chronic rhi- (5) Diphenhydramine citrate. nitis. (6) Diphenhydramine hydrochloride. 236 VerDate 11<MAY>2000 11:17 May 11, 2001 Jkt 194066 PO 00000 Frm 00236 Fmt 8010 Sfmt 8010 Y:\SGML\194066T.XXX pfrm13 PsN: 194066T.