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262 Part 341—Cold, Cough, Al- Lergy, Bronchodilator, And

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262 Part 341—Cold, Cough, Al- Lergy, Bronchodilator, And Pt. 341 21 CFR Ch. I (4–1–18 Edition) section 502 of the Act relating to mis- treating concurrent symptoms (in either branding and the prohibition in section a single-ingredient or combination drug 301(d) of the Act against the introduc- product). tion or delivery for introduction into 341.72 Labeling of antihistamine drug prod- interstate commerce of unapproved ucts. 341.74 Labeling of antitussive drug prod- new drugs in violation of section 505(a) ucts. of the Act. 341.76 Labeling of bronchodilator drug prod- (c) Warnings. The labeling of the ucts. product contains the following warn- 341.78 Labeling of expectorant drug prod- ings under the heading ‘‘Warnings’’: ucts. (1) ‘‘The recommended dose of this 341.80 Labeling of nasal decongestant drug product contains about as much caf- products. feine as a cup of coffee. Limit the use 341.85 Labeling of permitted combinations of caffeine-containing medications, of active ingredients. foods, or beverages while taking this 341.90 Professional labeling. product because too much caffeine may AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, cause nervousness, irritability, sleep- 360, 371. lessness, and, occasionally, rapid heart EDITORIAL NOTE: Nomenclature changes to beat.’’ part 341 appear at 69 FR 13717, Mar. 24, 2004. (2) ‘‘For occasional use only. Not in- tended for use as a substitute for sleep. Subpart A—General Provisions If fatigue or drowsiness persists or con- tinues to recur, consult a’’ (select one § 341.1 Scope. of the following: ‘‘physician’’ or ‘‘doc- tor’’). (a) An over-the-counter cold, cough, (3) ‘‘Do not give to children under 12 allergy, bronchodilator, or anti- years of age.’’ asthmatic drug product in a form suit- (d) Directions. The labeling of the able for oral, inhalant, or topical ad- product contains the following infor- ministration is generally recognized as mation under the heading ‘‘Direc- safe and effective and is not mis- tions’’: Adults and children 12 years of branded if it meets each of the condi- 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. as in the symptomatic treatment of 341.3 Definitions. 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. 262 VerDate Sep<11>2014 11:29 Jun 12, 2018 Jkt 244074 PO 00000 Frm 00272 Fmt 8010 Sfmt 8010 Y:\SGML\244074.XXX 244074 nshattuck on DSK9F9SC42PROD with CFR Food and Drug Administration, HHS § 341.20 (d) Expectorant drug. A drug taken (m) Triprolidine hydrochloride. orally to promote or facilitate the re- [57 FR 58374, Dec. 9, 1992, as amended at 59 moval of secretions from the res- FR 4218, Jan. 28, 1994] piratory airways. (e) Antihistamine drug. A drug used § 341.14 Antitussive active ingredients. for the relief of the symptoms of hay The active ingredients of the product fever and upper respiratory allergies consist of any of the following when (allergic rhinitis). used within the dosage limits and in (f) Oral nasal decongestant drug. A the dosage forms established for each drug that is taken by mouth and acts ingredient in § 341.74(d): systemically to reduce nasal conges- (a) Oral antitussives. (1) Chlophedianol tion caused by acute or chronic rhi- hydrochloride. nitis. (2) Codeine ingredients. The following (g) Topical nasal decongestant drug. A ingredients may be used only in com- drug that when applied topically inside bination in accordance with § 290.2 and the nose, in the form of drops, jellies, 21 CFR 1308.15(c). or sprays, or when inhaled intranasally (i) Codeine. reduces nasal congestion caused by (ii) Codeine phosphate. acute or chronic rhinitis. (iii) Codeine sulfate. (h) Calibrated dropper. A dropper cali- (3) Dextromethorphan. brated such that the volume error in- (4) Dextromethorphan hydrobromide. curred in measuring any liquid does (5) Diphenhydramine citrate. not exceed 15 percent under normal use (6) Diphenhydramine hydrochloride. conditions. (b) Topical antitussives. (1) Camphor. (i) Effervescent dosage form. A dosage (2) Menthol. form intended to be dissolved in water [52 FR 30055, Aug. 12, 1987, as amended at 59 before administration. It contains, in FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002] addition to the active ingredient(s), mixtures of acids (citric acid, tartaric § 341.16 Bronchodilator active ingredi- acid) and sodium bicarbonate, which ents. release carbon dioxide when dissolved The active ingredients of the product in water. consist of any of the following when used within the dosage limits estab- [51 FR 35339, Oct. 2, 1986, as amended at 54 FR lished for each ingredient: 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 (a) Ephedrine. FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, 1994; 71 FR 43362, Aug. 1, 2006] (b) Ephedrine hydrochloride. (c) Ephedrine sulfate. (d) Epinephrine. Subpart B—Active Ingredients (e) Epinephrine bitartrate. (f) Racephedrine hydrochloride. § 341.12 Antihistamine active ingredi- (g) Racepinephrine hydrochloride. ents. [51 FR 35339, Oct. 2, 1986] The active ingredient of the product consists of any of the following when § 341.18 Expectorant active ingredient. used within the dosage limits estab- lished for each ingredient: The active ingredient of the product is guaifenesin when used within the (a) Brompheniramine maleate. dosage limits established in § 341.78(d). (b) Chlorcyclizine hydrochloride. (c) Chlorpheniramine maleate. [54 FR 8509, Feb. 28, 1989] (d) Dexbrompheniramine maleate. § 341.20 Nasal decongestant active in- (e) Dexchlorpheniramine maleate. gredients. (f) Diphenhydramine citrate. The active ingredient of the product (g) Diphenhydramine hydrochloride. consists of any of the following when (h) Doxylamine succinate. used within the dosage limits and in (i) Phenindamine tartrate. the dosage forms established for each (j) Pheniramine maleate. ingredient: (k) Pyrilamine maleate. (a) Oral nasal decongestants. (1) Phen- (l) Thonzylamine hydrochloride. ylephrine hydrochloride. 263 VerDate Sep<11>2014 11:29 Jun 12, 2018 Jkt 244074 PO 00000 Frm 00273 Fmt 8010 Sfmt 8010 Y:\SGML\244074.XXX 244074 nshattuck on DSK9F9SC42PROD with CFR.
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