Food and Drug Administration, HHS § 341.3 age and over: Oral dosage is 100 to 200 tions in this part and each of the gen- milligrams not more often than every 3 eral conditions established in § 330.1. to 4 hours. (b) References in this part to regu- latory sections of the Code of Federal PART 341—COLD, COUGH, AL- Regulations are to chapter I of title 21 LERGY, BRONCHODILATOR, AND unless otherwise noted. ANTIASTHMATIC DRUG PROD- [51 FR 35339, Oct. 2, 1986] UCTS FOR OVER-THE-COUNTER HUMAN USE § 341.3 Definitions. As used in this part: Subpart A—General Provisions (a) Bronchodilator drug. A drug used to overcome spasms that cause nar- Sec. rowing of the bronchial air tubes, such 341.1 Scope. 341.3 Definitions. as in the symptomatic treatment of the wheezing and shortness of breath of Subpart B—Active Ingredients asthma. (b) Oral antitussive drug. A drug that 341.12 Antihistamine active ingredients. either is taken by mouth or is dis- 341.14 Antitussive active ingredients. solved in the mouth in the form of a 341.16 Bronchodilator active ingredients. 341.18 Expectorant active ingredient. lozenge and acts systemically to re- 341.20 Nasal decongestant active ingredi- lieve cough. ents. (c) Topical antitussive drug. A drug 341.40 Permitted combinations of active in- that relieves cough when inhaled after gredients. being applied topically to the throat or chest in the form of an ointment or Subpart C—Labeling from a steam vaporizer, or when dis- 341.70 Labeling of OTC drug products con- solved in the mouth in the form of a taining ingredients that are used for lozenge for a local effect. treating concurrent symptoms (in either (d) Expectorant drug. A drug taken a single-ingredient or combination drug orally to promote or facilitate the re- product). moval of secretions from the res- 341.72 Labeling of antihistamine drug prod- piratory airways. ucts. (e) Antihistamine drug. A drug used 341.74 Labeling of antitussive drug prod- ucts. for the relief of the symptoms of hay 341.76 Labeling of bronchodilator drug prod- fever and upper respiratory allergies ucts. (allergic rhinitis). 341.78 Labeling of expectorant drug prod- (f) Oral nasal decongestant drug. A ucts. drug that is taken by mouth and acts 341.80 Labeling of nasal decongestant drug systemically to reduce nasal conges- products. tion caused by acute or chronic rhi- 341.85 Labeling of permitted combinations nitis. of active ingredients. 341.90 Professional labeling. (g) Topical nasal decongestant drug. A drug that when applied topically inside AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, the nose, in the form of drops, jellies, 360, 371. or sprays, or when inhaled intranasally EDITORIAL NOTE: Nomenclature changes to reduces nasal congestion caused by part 341 appear at 69 FR 13717, Mar. 24, 2004. acute or chronic rhinitis. (h) Calibrated dropper. A dropper cali- Subpart A—General Provisions brated such that the volume error in- curred in measuring any liquid does § 341.1 Scope. 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 243 VerDate Mar<15>2010 14:51 May 15, 2012 Jkt 226071 PO 00000 Frm 00253 Fmt 8010 Sfmt 8010 Y:\SGML\226071.XXX 226071 emcdonald on DSK7TPTVN1PROD with CFR § 341.12 21 CFR Ch. I (4–1–12 Edition) release carbon dioxide when dissolved § 341.16 Bronchodilator active ingredi- in water. ents. [51 FR 35339, Oct. 2, 1986, as amended at 54 FR The active ingredients of the product 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 consist of any of the following when FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, used within the dosage limits estab- 1994; 71 FR 43362, Aug. 1, 2006] lished for each ingredient: (a) Ephedrine. Subpart B—Active Ingredients (b) Ephedrine hydrochloride. (c) Ephedrine sulfate. § 341.12 Antihistamine active ingredi- (d) Epinephrine. ents. (e) Epinephrine bitartrate. The active ingredient of the product (f) Racephedrine hydrochloride. (g) Racepinephrine hydrochloride. consists of any of the following when used within the dosage limits estab- [51 FR 35339, Oct. 2, 1986] lished for each ingredient: (a) Brompheniramine maleate. § 341.18 Expectorant active ingredient. (b) Chlorcyclizine hydrochloride. The active ingredient of the product (c) Chlorpheniramine maleate. is guaifenesin when used within the (d) Dexbrompheniramine maleate. dosage limits established in § 341.78(d). (e) Dexchlorpheniramine maleate. [54 FR 8509, Feb. 28, 1989] (f) Diphenhydramine citrate. (g) Diphenhydramine hydrochloride. § 341.20 Nasal decongestant active in- gredients. (h) Doxylamine succinate. (i) Phenindamine tartrate. The active ingredient of the product (j) Pheniramine maleate. consists of any of the following when (k) Pyrilamine maleate. used within the dosage limits and in the dosage forms established for each (l) Thonzylamine hydrochloride. ingredient: (m) Triprolidine hydrochloride. (a) Oral nasal decongestants. (1) Phen- [57 FR 58374, Dec. 9, 1992, as amended at 59 ylephrine hydrochloride. FR 4218, Jan. 28, 1994] (2) Pseudoephedrine hydrochloride. (3) Pseudoephedrine sulfate. § 341.14 Antitussive active ingredients. (4) Phenylephrine bitartrate in an ef- The active ingredients of the product fervescent dosage form. consist of any of the following when (b) Topical nasal decongestants. (1) used within the dosage limits and in Levmetamfetamine. the dosage forms established for each (2) Ephedrine. (3) Ephedrine hydrochloride. ingredient in § 341.74(d): (4) Ephedrine sulfate. (a) Oral antitussives. (1) Chlophedianol (5) [Reserved] hydrochloride. (6) Naphazoline hydrochloride. (2) Codeine ingredients. The following (7) Oxymetazoline hydrochloride. ingredients may be used only in com- (8) Phenylephrine hydrochloride. bination in accordance with § 290.2 and (9) Propylhexedrine. 21 CFR 1308.15(c). (10) Xylometazoline hydrochloride. (i) Codeine. (ii) Codeine phosphate. [59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, (iii) Codeine sulfate. 2006] (3) Dextromethorphan. (4) Dextromethorphan hydrobromide. § 341.40 Permitted combinations of ac- (5) Diphenhydramine citrate. tive ingredients. (6) Diphenhydramine hydrochloride. The following combinations are per- (b) Topical antitussives. (1) Camphor. mitted provided each active ingredient (2) Menthol. is present within the dosage limits es- tablished in parts 341, 343, and 356 of [52 FR 30055, Aug. 12, 1987, as amended at 59 this chapter and the product is labeled FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002] in accordance with §§ 341.70 or 341.85: 244 VerDate Mar<15>2010 14:51 May 15, 2012 Jkt 226071 PO 00000 Frm 00254 Fmt 8010 Sfmt 8010 Y:\SGML\226071.XXX 226071 emcdonald on DSK7TPTVN1PROD with CFR.