Food and Drug Administration, HHS § 341.72

Home , Dexbrompheniramine, Dexchlorpheniramine

this chapter. The product contains 5 to piratory allergies’’ or ‘‘(allergic rhi- 10 milligrams menthol. The labeling of nitis)’’). the product contains the established (2) ‘‘For the temporary relief of name of the drug, if any, and identifies runny nose, sneezing, itching of the the product as a ‘‘cough suppressant/ nose or throat, and itchy, watery eyes oral anesthetic’’ or ‘‘antitussive (cough due to hay fever’’ (which may be fol- suppressant)/oral anesthetic.’’ The in- lowed by one or both of the following: dications shall be combined from ‘‘or other upper respiratory allergies’’ § 341.74(b) and part 356 of this chapter. or ‘‘(allergic rhinitis)’’). The warnings shall be combined from (c) Warnings. The labeling of the § 341.74(c)(1), (c)(2), and (c)(3) and part product contains the following warn- 356 of this chapter. The directions shall ings, under the heading ‘‘Warnings’’: be: ‘‘Directions [in bold type] [bullet] 1 (1) ‘‘May cause excitability especially adults and children 2 years and over: in children.’’ dissolve lozenge slowly in the mouth. (2) ‘‘Do not take this product, unless Repeat every 2 hours as needed or as directed by a doctor, if you have a directed by a doctor. [bullet] children breathing problem such as emphysema under 2 years of age: ask a doctor’’. or chronic bronchitis, or if you have [61 FR 15703, Apr. 9, 1996, as amended at 67 glaucoma or difficulty in urination due FR 78170, Dec. 23, 2002; 68 FR 17881, Apr. 14, to enlargement of the prostate gland.’’ 2003] (3) For products containing brompheniramine maleate, chlorcyclizine § 341.72 Labeling of antihistamine hydrochloride, chlorpheniramine maleate, drug products. dexbrompheniramine maleate, (a) Statement of identity. The labeling dexchlorpheniramine maleate, of the product contains the established phenindamine tartrate, pheniramine male- name of the drug, if any, and identifies ate, pyrilamine maleate, thonzylamine hy- the product as an ‘‘antihistamine.’’ drochloride, or triprolidine hydrochloride (b) Indications. The labeling of the identified in § 341.12(a), (b), (c), (d), (e), product states, under the heading ‘‘In- (i), (j), (k), (l), and (m). ‘‘May cause dications,’’ any of the phrases listed in drowsiness; alcohol, sedatives, and paragraph (b) of this section, as appro- tranquilizers may increase the drowsi- priate. Other truthful and nonmis- ness effect. Avoid alcoholic beverages leading statements, describing only the while taking this product. Do not take indications for use that have been es- this product if you are taking sedatives tablished and listed in this paragraph, or tranquilizers, without first con- may also be used, as provided in sulting your doctor. Use caution when § 330.1(c)(2) of this chapter, subject to driving a motor vehicle or operating the provisions of section 502 of the Fed- machinery.’’ eral Food, Drug, and Cosmetic Act (the (4) For products containing act) relating to misbranding and the diphenhydramine citrate, prohibition in section 301(d) of the act diphenhydramine hydrochloride, or against the introduction or delivery for doxylamine succinate identified in introduction into interstate commerce § 341.12(f), (g), and (h). ‘‘May cause of unapproved new drugs in violation of marked drowsiness; alcohol, sedatives, section 505(a) of the act. and tranquilizers may increase the (1) ‘‘Temporarily’’ (select one of the drowsiness effect. Avoid alcoholic bev- following: ‘‘relieves,’’ ‘‘alleviates,’’ erages while taking this product. Do ‘‘decreases,’’ ‘‘reduces,’’ or ‘‘dries’’) not take this product if you are taking ‘‘runny nose and’’ (select one of the fol- sedatives or tranquilizers, without first lowing: ‘‘relieves,’’ ‘‘alleviates,’’ ‘‘de- consulting your doctor. Use caution creases,’’ or ‘‘reduces’’) ‘‘sneezing, when driving a motor vehicle or oper- itching of the nose or throat, and ating machinery.’’ itchy, watery eyes due to hay fever’’ (5) For products containing (which may be followed by one or both phenindamine tartrate identified in of the following: ‘‘or other upper res- § 341.12(i). ‘‘May cause nervousness and insomnia in some individuals.’’ 1 See § 201.66(b)(4) of this chapter for defini- (6) For products that are labeled only tion of bullet symbol. for use by children under 12 years of age.

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The labeling of the product contains of age and over: oral dosage is 4 milli- only the warnings identified in para- grams every 4 to 6 hours, not to exceed graphs (c)(1) and (c)(5) of this section as 24 milligrams in 24 hours, or as di- well as the following: rected by a doctor. Children 6 to under (i) ‘‘Do not give this product to chil- 12 years of age: oral dosage is 2 milli- dren who have a breathing problem grams every 4 to 6 hours, not to exceed such as chronic bronchitis, or who have 12 milligrams in 24 hours, or as di- glaucoma, without first consulting the rected by a doctor. Children under 6 child’s doctor.’’ years of age: consult a doctor. (ii) For products containing (2) For products containing brompheniramine maleate, chlorcyclizine hydrochloride identified in chlorpheniramine maleate, § 341.12(b). Adults and children 12 years dexbrompheniramine maleate, of age and over: oral dosage is 25 milli- dexchlorpheniramine maleate, grams every 6 to 8 hours, not to exceed phenindamine tartrate, pheniramine male- 75 milligrams in 24 hours, or as di- ate, pyrilamine maleate, thonzylamine hy- rected by a doctor. Children under 12 drochloride, or triprolidine hydrochloride years of age: consult a doctor. identified in § 341.12(a), (c), (d), (e), (i), (3) For products containing (j), (k), (l), and (m). ‘‘May cause drowsi- chlorpheniramine maleate identified in ness. Sedatives and tranquilizers may § 341.12(c). Adults and children 12 years increase the drowsiness effect. Do not of age and over: oral dosage is 4 milli- give this product to children who are grams every 4 to 6 hours, not to exceed taking sedatives or tranquilizers, with- 24 milligrams in 24 hours, or as di- out first consulting the child’s doctor.’’ rected by a doctor. Children 6 to under (iii) For products containing 12 years of age: oral dosage is 2 milli- diphenhydramine citrate, grams every 4 to 6 hours, not to exceed diphenhydramine hydrochloride, or 12 milligrams in 24 hours, or as di- doxylamine succinate identified in rected by a doctor. Children under 6 § 341.12(f), (g), and (h). ‘‘May cause years of age: consult a doctor. marked drowsiness. Sedatives and (4) For products containing tranquilizers may increase the drowsi- dexbrompheniramine maleate identified in ness effect. Do not give this product to § 341.12(d). Adults and children 12 years children who are taking sedatives or of age and over: oral dosage is 2 milli- tranquilizers, without first consulting grams every 4 to 6 hours, not to exceed the child’s doctor.’’ 12 milligrams in 24 hours, or as di- (iv) For products containing rected by a doctor. Children 6 to under diphenhydramine citrate or 12 years of age: oral dosage is 1 milli- diphenhydramine hydrochloride identified gram every 4 to 6 hours, not to exceed in § 341.12(f) and (g). ‘‘Do not use [bul- 6 milligrams in 24 hours, or as directed let] 1 with any other product con- by a doctor. Children under 6 years of taining diphenhydramine, even one age: consult a doctor. used on skin’’. (5) For products containing (7) For products containing dexchlorpheniramine maleate identified in diphenhydramine citrate or § 341.12(e). Adults and children 12 years diphenhydramine hydrochloride identified of age and over: oral dosage is 2 milli- in § 341.12(f) and (g). ‘‘Do not use [bul- grams every 4 to 6 hours, not to exceed let] with any other product containing 12 milligrams in 24 hours, or as di- diphenhydramine, even one used on rected by a doctor. Children 6 to under skin’’. 12 years of age: oral dosage is 1 milli- (d) Directions. The labeling of the gram every 4 to 6 hours, not to exceed product contains the following infor- 6 milligrams in 24 hours, or as directed mation under the heading ‘‘Direc- by a doctor. Children under 6 years of tions’’: age: consult a doctor. (1) For products containing (6) For products containing brompheniramine maleate identified in diphenhydramine citrate identified in § 341.12(a). Adults and children 12 years § 341.12(f). Adults and children 12 years of age and over: oral dosage is 38 to 76 1 See § 201.66(b)(4) of this chapter for defini- milligrams every 4 to 6 hours, not to tion of bullet symbol. exceed 456 milligrams in 24 hours, or as

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directed by a doctor. Children 6 to oral dosage is 25 to 50 milligrams every under 12 years of age: oral dosage is 19 6 to 8 hours, not to exceed 200 milli- to 38 milligrams every 4 to 6 hours, not grams in 24 hours, or as directed by a to exceed 228 milligrams in 24 hours, or doctor. Children 6 to under 12 years of as directed by a doctor. Children under age: oral dosage is 12.5 to 25 milligrams 6 years of age: consult a doctor. every 6 to 8 hours, not to exceed 100 (7) For products containing milligrams in 24 hours, or as directed diphenhydramine hydrochloride identified by a doctor. Children under 6 years of in § 341.12(g). Adults and children 12 age: consult a doctor. years of age and over: oral dosage is 25 (12) For products containing thonzyl- to 50 milligrams every 4 to 6 hours, not amine hydrochloride identified in to exceed 300 milligrams in 24 hours, or § 341.12(l). Adults and children 12 years as directed by a doctor. Children 6 to of age and over: oral dosage is 50 to 100 under 12 years of age: oral dosage is milligrams every 4 to 6 hours, not to 12.5 to 25 milligrams every 4 to 6 hours, exceed 600 milligrams in 24 hours, or as not to exceed 150 milligrams in 24 directed by a doctor. Children 6 to hours, or as directed by a doctor. Chil- under 12 years of age: oral dosage is 25 dren under 6 years of age: consult a to 50 milligrams every 4 to 6 hours, not doctor. to exceed 300 milligrams in 24 hours, or (8) For products containing doxylamine as directed by a doctor. Children under succinate identified in § 341.12(h). Adults 6 years of age: consult a doctor. and children 12 years of age and over: (13) For products containing triprolidine oral dosage is 7.5 to 12.5 milligrams hydrochloride identified in § 341.12(m). every 4 to 6 hours, not to exceed 75 mil- Adults and children 12 years of age and ligrams in 24 hours, or as directed by a over: oral dosage is 2.5 milligrams doctor. Children 6 to under 12 years of every 4 to 6 hours, not to exceed 10 mil- age: oral dosage is 3.75 to 6.25 milli- ligrams in 24 hours, or as directed by a grams every 4 to 6 hours, not to exceed doctor. Children 6 to under 12 years of 37.5 milligrams in 24 hours, or as di- age: oral dosage is 1.25 milligrams rected by a doctor. Children under 6 every 4 to 6 hours, not to exceed 5 mil- years of age: consult a doctor. ligrams in 24 hours, or as directed by a (9) For products containing doctor. Children under 6 years of age: phenindamine tartrate identified in consult a doctor. § 341.12(i). Adults and children 12 years (e) The word ‘‘physician’’ may be sub- of age and over: oral dosage is 25 milli- stituted for the word ‘‘doctor’’ in any grams every 4 to 6 hours, not to exceed of the labeling statements in this sec- 150 milligrams in 24 hours, or as di- tion. rected by a doctor. Children 6 to under [57 FR 58374, Dec. 9, 1992, as amended at 59 12 years of age: oral dosage is 12.5 milli- FR 4218, Jan. 28, 1994; 67 FR 72559, Dec. 6, grams every 4 to 6 hours, not to exceed 2002] 75 milligrams in 24 hours, or as directed by a doctor. Children under 6 § 341.74 Labeling of antitussive drug years of age: consult a doctor. products. (10) For products containing (a) Statement of identity. The labeling pheniramine maleate identified in of the product contains the established § 341.12(j). Adults and children 12 years name of the drug, if any, and identifies of age and over: oral dosage is 12.5 to 25 the product as a ‘‘cough suppressant’’ milligrams every 4 to 6 hours, not to or an ‘‘antitussive (cough suppres- exceed 150 milligrams in 24 hours, or as sant).’’ directed by a doctor. Children 6 to (b) Indications. The labeling of the under 12 years of age: oral dosage is product states, under the heading ‘‘In- 6.25 to 12.5 milligrams every 4 to 6 dications,’’ any of the phrases listed in hours, not to exceed 75 milligrams in 24 this paragraph (b), as appropriate. hours, or as directed by a doctor. Chil- Other truthful and nonmisleading dren under 6 years of age: consult a statements, describing only the indica- doctor. tions for use that have been established (11) For products containing pyrilamine and listed in this paragraph, may also maleate identified in § 341.12(k). Adults be used, as provided in § 330.1(c)(2), sub- and children 12 years of age and over: ject to the provisions of section 502 of

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