235 Part 340—Stimulant Drug Products For

Food and Drug Administration, HHS § 340.50

(4) ‘‘Avoid alcoholic beverages while Subpart A—General Provisions taking this product. Do not take this product if you are taking sedatives or § 340.1 Scope. tranquilizers, without first consulting (a) An over-the-counter stimulant your doctor.’’ drug product in a form suitable for oral (5) ‘‘Do not use [bullet]1 with any administration is generally recognized other product containing as safe and effective and is not mis- diphenhydramine, even one used on branded if it meets each of the condi- skin’’. tions in this part and each of the gen- (d) Directions. The labeling of the eral conditions established in § 330.1. product contains the following infor- (b) References in this part to regu- mation under the heading ‘‘Direc- latory sections of the Code of Federal tions’’: Regulations are to chapter I of title 21 (1) For products containing unless otherwise noted. diphenhydramine hydrochloride identified in § 338.10(a). Adults and children 12 § 340.3 Definition. years of age and over: Oral dosage is 50 As used in this part: milligrams at bedtime if needed, or as Stimulant. A drug which helps restore directed by a doctor. mental alertness or wakefulness during (2) For products containing fatigue or drowsiness. diphenhydramine citrate identified in § 338.10(b). Adults and children 12 years Subpart B—Active Ingredient of age and over: Oral dosage is 76 milligrams at bedtime if needed, or as di- § 340.10 Stimulant active ingredient. rected by a doctor. (e) The word ‘‘physician’’ may be sub- The active ingredient of the product consists of caffeine when used within stituted for the word ‘‘doctor’’ in any the dosage limits established in of the labeling statements in this sec- § 340.50(d). tion. [54 FR 6826, Feb. 14, 1989, as amended at 59 Subpart C—Labeling FR 16983, Apr. 11, 1994; 67 FR 72559, Dec. 6, 2002] § 340.50 Labeling of stimulant drug products. PART 340—STIMULANT DRUG (a) Statement of identity. The labeling PRODUCTS FOR OVER-THE- of the product contains the established COUNTER HUMAN USE name of the drug, if any, and identifies the product as an ‘‘altertness aid’’ or a Subpart A—General Provisions ‘‘stimulant.’’ (b) Indications. The labeling of the Sec. product states, under the heading ‘‘In- 340.1 Scope. 340.3 Definition. dications,’’ the following: ‘‘Helps restore mental alertness or wakefulness Subpart B—Active Ingredient when experiencing fatigue or drowsiness.’’ Other truthful and nonmis- 340.10 Stimulant active ingredient. leading statements, describing only the indications for use that have been es- Subpart C—Labeling tablished and listed in this paragraph 340.50 Labeling of stimulant drug products. (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, section 502 of the Act relating to mis- 360, 371. branding and the prohibition in section SOURCE: 53 FR 6105, Feb. 29, 1988, unless 301(d) of the Act against the introduc- otherwise noted. tion or delivery for introduction into interstate commerce of unapproved 1 See § 201.66(b)(4) of this chapter for defini- new drugs in violation of section 505(a) tion of bullet symbol. of the Act.

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(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 decongestant drug 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 cause nervousness, irritability, sleep- AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. lessness, and, occasionally, rapid heart 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, 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 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 asthma. (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

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