Food and Administration, HHS § 341.3

(c) Warnings. The labeling of the 341.76 Labeling of bronchodilator drug prod- product contains the following warn- ucts. ings under the heading ‘‘Warnings’’: 341.78 Labeling of expectorant drug prod- (1) ‘‘The recommended dose of this ucts. product contains about as much caf- 341.80 Labeling of nasal drug products. feine as a cup of coffee. Limit the use 341.85 Labeling of permitted combinations of caffeine-containing , of active ingredients. foods, or beverages while taking this 341.90 Professional labeling. product because too much caffeine may cause nervousness, irritability, sleep- AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. lessness, and, occasionally, rapid beat.’’ EDITORIAL NOTE: Nomenclature changes to (2) ‘‘For occasional use only. Not in- part 341 appear at 69 FR 13717, Mar. 24, 2004. tended for use as a substitute for sleep. If fatigue or drowsiness persists or con- Subpart A—General Provisions tinues to recur, consult a’’ (select one of the following: ‘‘physician’’ or ‘‘doc- § 341.1 Scope. 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, , 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 Sec. to overcome spasms that cause nar- 341.1 Scope. rowing of the bronchial air tubes, such 341.3 Definitions. as in the symptomatic treatment of the wheezing and shortness of breath of Subpart B—Active Ingredients . (b) Oral antitussive drug. A drug that 341.12 Antihistamine active ingredients. 341.14 Antitussive active ingredients. either is taken by mouth or is dis- 341.16 Bronchodilator active ingredients. solved in the mouth in the form of a 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 Subpart C—Labeling chest in the form of an ointment or 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). 341.72 Labeling of antihistamine drug prod- moval of secretions from the res- ucts. piratory airways. 341.74 Labeling of antitussive drug prod- (e) Antihistamine drug. A drug used ucts. for the relief of the symptoms of hay

247

VerDate Sep<11>2014 14:08 Jun 03, 2016 Jkt 238074 PO 00000 Frm 00257 Fmt 8010 Sfmt 8010 Y:\SGML\238074.XXX 238074 ehiers on DSK5VPTVN1PROD with CFR § 341.12 21 CFR Ch. I (4–1–16 Edition)

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. (h) Calibrated dropper. A dropper cali- (5) Diphenhydramine citrate. brated such that the volume error in- (6) Diphenhydramine hydrochloride. curred in measuring any liquid does (b) Topical antitussives. (1) Camphor. not exceed 15 percent under normal use (2) Menthol. conditions. (i) Effervescent dosage form. A dosage [52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002] form intended to be dissolved in water before administration. It contains, in § 341.16 Bronchodilator active ingredi- addition to the active ingredient(s), ents. mixtures of acids (citric acid, tartaric The active ingredients of the product acid) and sodium bicarbonate, which consist of any of the following when release carbon dioxide when dissolved used within the dosage limits estab- in water. lished for each ingredient: [51 FR 35339, Oct. 2, 1986, as amended at 54 FR (a) . 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 (b) Ephedrine hydrochloride. FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, (c) Ephedrine sulfate. 1994; 71 FR 43362, Aug. 1, 2006] (d) . (e) Epinephrine bitartrate. Subpart B—Active Ingredients (f) Racephedrine hydrochloride. (g) Racepinephrine hydrochloride. § 341.12 Antihistamine active ingredi- ents. [51 FR 35339, Oct. 2, 1986] The active ingredient of the product § 341.18 Expectorant active ingredient. consists of any of the following when used within the dosage limits estab- The active ingredient of the product lished for each ingredient: is guaifenesin when used within the (a) Brompheniramine maleate. dosage limits established in § 341.78(d). (b) Chlorcyclizine hydrochloride. [54 FR 8509, Feb. 28, 1989] (c) Chlorpheniramine maleate. (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 . (1) Phen- (l) Thonzylamine hydrochloride. ylephrine hydrochloride. (m) Triprolidine hydrochloride. (2) Pseudoephedrine hydrochloride. [57 FR 58374, Dec. 9, 1992, as amended at 59 (3) Pseudoephedrine sulfate. FR 4218, Jan. 28, 1994] (4) Phenylephrine bitartrate in an ef- fervescent dosage form. § 341.14 Antitussive active ingredients. (b) Topical nasal decongestants. (1) The active ingredients of the product Levmetamfetamine. consist of any of the following when (2) Ephedrine. used within the dosage limits and in (3) Ephedrine hydrochloride.

248

VerDate Sep<11>2014 14:08 Jun 03, 2016 Jkt 238074 PO 00000 Frm 00258 Fmt 8010 Sfmt 8010 Y:\SGML\238074.XXX 238074 ehiers on DSK5VPTVN1PROD with CFR