§ 341.1 21 CFR Ch. I (4–1–10 Edition) Subpart A—General Provisions (h) Calibrated dropper. A dropper cali- brated such that the volume error in- § 341.1 Scope. curred in measuring any liquid does not exceed 15 percent under normal use (a) An over-the-counter cold, cough, conditions. allergy, bronchodilator, or anti- (i) Effervescent dosage form. A dosage asthmatic drug product in a form suit- form intended to be dissolved in water able for oral, inhalant, or topical ad- before administration. It contains, in ministration is generally recognized as addition to the active ingredient(s), safe and effective and is not mis- mixtures of acids (citric acid, tartaric branded if it meets each of the condi- acid) and sodium bicarbonate, which tions in this part and each of the gen- release carbon dioxide when dissolved eral conditions established in § 330.1. in water. (b) References in this part to regu- latory sections of the Code of Federal [51 FR 35339, Oct. 2, 1986, as amended at 54 FR Regulations are to chapter I of title 21 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, unless otherwise noted. 1994; 71 FR 43362, Aug. 1, 2006] [51 FR 35339, Oct. 2, 1986] Subpart B—Active Ingredients § 341.3 Definitions. § 341.12 Antihistamine active ingredi- As used in this part: ents. (a) Bronchodilator drug. A drug used The active ingredient of the product to overcome spasms that cause nar- consists of any of the following when rowing of the bronchial air tubes, such used within the dosage limits estab- as in the symptomatic treatment of lished for each ingredient: the wheezing and shortness of breath of (a) Brompheniramine maleate. asthma. (b) Chlorcyclizine hydrochloride. (b) Oral antitussive drug. A drug that (c) Chlorpheniramine maleate. either is taken by mouth or is dis- (d) Dexbrompheniramine maleate. solved in the mouth in the form of a (e) Dexchlorpheniramine maleate. lozenge and acts systemically to re- (f) Diphenhydramine citrate. lieve cough. (g) Diphenhydramine hydrochloride. (c) Topical antitussive drug. A drug (h) Doxylamine succinate. that relieves cough when inhaled after (i) Phenindamine tartrate. being applied topically to the throat or (j) Pheniramine maleate. chest in the form of an ointment or (k) Pyrilamine maleate. from a steam vaporizer, or when dis- (l) Thonzylamine hydrochloride. solved in the mouth in the form of a (m) Triprolidine hydrochloride. lozenge for a local effect. [57 FR 58374, Dec. 9, 1992, as amended at 59 (d) Expectorant drug. A drug taken FR 4218, Jan. 28, 1994] orally to promote or facilitate the re- moval of secretions from the res- § 341.14 Antitussive active ingredients. piratory airways. The active ingredients of the product (e) Antihistamine drug. A drug used consist of any of the following when for the relief of the symptoms of hay used within the dosage limits and in fever and upper respiratory allergies the dosage forms established for each (allergic rhinitis). ingredient in § 341.74(d): (f) Oral nasal decongestant drug. A (a) Oral antitussives. (1) Chlophedianol drug that is taken by mouth and acts hydrochloride. systemically to reduce nasal conges- (2) Codeine ingredients. The following tion caused by acute or chronic rhi- ingredients may be used only in com- nitis. bination in accordance with §§ 290.2 and (g) Topical nasal decongestant drug. A 21 CFR 1308.15(c). drug that when applied topically inside (i) Codeine. the nose, in the form of drops, jellies, (ii) Codeine phosphate. or sprays, or when inhaled intranasally (iii) Codeine sulfate. reduces nasal congestion caused by (3) Dextromethorphan. acute or chronic rhinitis. (4) Dextromethorphan hydrobromide. 242 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00252 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR.