PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Editorial Note: Nomenclature changes to part 341 appear at 69 FR 13717, Mar. 24, 2004. Subpart A—General Provisions § 341.1 Scope. (a) An over-the-counter cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. [51 FR 35339, Oct. 2, 1986] § 341.3 Definitions. As used in this part: (a) Bronchodilator drug. (b) Oral antitussive drug. (c) Topical antitussive drug. (d) Expectorant drug. (e) Antihistamine drug. (f) Oral nasal decongestant drug. (g) Topical nasal decongestant drug. (h) Calibrated dropper. (i) Effervescent dosage form. [51 FR 35339, Oct. 2, 1986, as amended at 54 FR 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, 1994; 71 FR 43362, Aug. 1, 2006] Subpart B—Active Ingredients § 341.12 Antihistamine active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient: (a) Brompheniramine maleate. (b) Chlorcyclizine hydrochloride. (c) Chlorpheniramine maleate. (d) Dexbrompheniramine maleate. (e) Dexchlorpheniramine maleate. (f) Diphenhydramine citrate. (g) Diphenhydramine hydrochloride. (h) Doxylamine succinate. (i) Phenindamine tartrate. (j) Pheniramine maleate. (k) Pyrilamine maleate. (l) Thonzylamine hydrochloride. (m) Triprolidine hydrochloride. [57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994] § 341.14 Antitussive active ingredients. The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in § 341.74(d): (a) Oral antitussives. (2) Codeine ingredients. (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3) Dextromethorphan. (4) Dextromethorphan hydrobromide. (5) Diphenhydramine citrate. (6) Diphenhydramine hydrochloride. (b) Topical antitussives. (2) Menthol. [52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002] § 341.16 Bronchodilator active ingredients. The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient: (a) Ephedrine. (b) Ephedrine hydrochloride. (c) Ephedrine sulfate. (d) Epinephrine. (e) Epinephrine bitartrate. (f) Racephedrine hydrochloride. (g) Racepinephrine hydrochloride. [51 FR 35339, Oct. 2, 1986] § 341.18 Expectorant active ingredient. The active ingredient of the product is guaifenesin when used within the dosage limits established in § 341.78(d). [54 FR 8509, Feb. 28, 1989] § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient: (a) Oral nasal decongestants. (2) Pseudoephedrine hydrochloride. (3) Pseudoephedrine sulfate. (4) Phenylephrine bitartrate in an effervescent dosage form. (b) Topical nasal decongestants. (2) Ephedrine. (3) Ephedrine hydrochloride. (4) Ephedrine sulfate. (5) [Reserved] (6) Naphazoline hydrochloride. (7) Oxymetazoline hydrochloride. (8) Phenylephrine hydrochloride. (9) Propylhexedrine. (10) Xylometazoline hydrochloride. [59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, 2006] § 341.40 Permitted combinations of active ingredients. The following combinations are permitted provided each active ingredient is present within the dosage limits established in parts 341, 343, and 356 of this chapter and the product is labeled in accordance with §§ 341.70 or 341.85: (a) Any single antihistamine active ingredient identified in § 341.12 may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (b) Any single antihistamine active ingredient identified in § 341.12 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85. (c) Any single antihistamine active ingredient identified in § 341.12 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (d) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a). (e) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) and any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a). (f) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a). (g) Any single antihistamine active ingredient identified in § 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) and any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85(c)(4). Diphenhydramine citrate in §§ 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in §§ 341.12(g) and 341.14(a)(6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to § 341.70(a). (h) Any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) may be combined with any single expectorant active ingredient identified in § 341.18 provided that the product is labeled according to § 341.85. (i) Any single oral antitussive active ingredient identified in § 341.14(a) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85. (j) Any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any single expectorant active ingredient identified in § 341.18 provided that the product is labeled according to § 341.85. (k) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. Menthol in § 341.14(b)(2) and part 356 of this chapter may be both the antitussive and the anesthetic/analgesic active ingredient provided that the product is labeled according to § 341.70(b). (l) Any single oral antitussive active ingredient identified in § 341.14(a) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (m) Any single oral antitussive active ingredient identified in § 341.14(a) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (n) Any single oral antitussive active ingredient identified in § 341.14(a)(1) through (a)(4) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any single expectorant active ingredient identified in § 341.18 and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (o) Any single expectorant active ingredient identified in § 341.18 may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (p) Any single expectorant active ingredient identified in § 341.18 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) provided that the product is labeled according to § 341.85. (q) Any single expectorant active ingredient identified in § 341.18 may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (r) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85. (s) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient identified, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. (t) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any single antitussive active ingredient identified in § 341.14(a) or (b)(2) and any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. (u) Camphor identified in § 341.14(b)(1) may be combined with menthol identified in § 341.14(b)(2) and eucalyptus oil (1.2 to 1.3 percent) provided that the product is available only in a suitable ointment vehicle and provided that the product is labeled according to § 341.85. (v) Levmetamfetamine identified in § 341.20(b)(1) may be combined with aromatics (camphor (54 milligrams (mg)), menthol (80 mg), methyl salicylate (11 mg), and lavender oil (4 mg)) provided that the product is available only as a nasal inhaler and provided that the product is labeled according to § 341.85. (w) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. (x) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. (y) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. (z) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient or any combination of anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. (aa) Any single oral nasal decongestant active ingredient identified in § 341.20(a) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient or any combination of oral anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. (bb) Any single antitussive active ingredient identified in § 341.14(a) or (b)(2) may be combined with any single oral nasal decongestant active ingredient identified in § 341.20(a) and any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient identified or any combination of anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to § 341.85. If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. [67 FR 78168, Dec. 23, 2002] Subpart C—Labeling § 341.70 Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product). The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. (a) For products containing diphenhydramine citrate and diphenhydramine hydrochloride identified in § 341.14(a)(5) and (a)(6). (b) For products containing menthol identified in §§ 341.14(b)(2) and 356.12(f) of this chapter. 1 1 [61 FR 15703, Apr. 9, 1996, as amended at 67 FR 78170, Dec. 23, 2002; 68 FR 17881, Apr. 14, 2003] § 341.72 Labeling of antihistamine drug products. (a) Statement of identity. (b) Indications. (1) “Temporarily” (select one of the following: “relieves,” “alleviates,” “decreases,” “reduces,” or “dries”) “runny nose and” (select one of the following: “relieves,” “alleviates,” “decreases,” or “reduces”) “sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever” (which may be followed by one or both of the following: “or other upper respiratory allergies” or “(allergic rhinitis)”). (2) “For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever” (which may be followed by one or both of the following: “or other upper respiratory allergies” or “(allergic rhinitis)”). (c) Warnings. (1) “May cause excitability especially in children.” (2) “Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.” (3) For products containing brompheniramine maleate, chlorcyclizine hydrochloride, chlorpheniramine maleate, dexbrompheniramine maleate, dexchlorpheniramine maleate, phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hydrochloride, or triprolidine hydrochloride identified in § 341.12(a), (b), (c), (d), (e), (i), (j), (k), (l), and (m). (4) For products containing diphenhydramine citrate, diphenhydramine hydrochloride, or doxylamine succinate identified in § 341.12(f), (g), and (h). (5) For products containing phenindamine tartrate identified in § 341.12(i). (6) For products that are labeled only for use by children under 12 years of age. (i) “Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.” (ii) For products containing brompheniramine maleate, chlorpheniramine maleate, dexbrompheniramine maleate, dexchlorpheniramine maleate, phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hydrochloride, or triprolidine hydrochloride identified in § 341.12(a), (c), (d), (e), (i), (j), (k), (l), and (m). (iii) For products containing diphenhydramine citrate, diphenhydramine hydrochloride, or doxylamine succinate identified in § 341.12(f), (g), and (h). (iv) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.12(f) and (g). 1 1 (7) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.12(f) and (g). (d) Directions. (1) For products containing brompheniramine maleate identified in § 341.12(a). (2) For products containing chlorcyclizine hydrochloride identified in § 341.12(b). (3) For products containing chlorpheniramine maleate identified in § 341.12(c). (4) For products containing dexbrompheniramine maleate identified in § 341.12(d). (5) For products containing dexchlorpheniramine maleate identified in § 341.12(e). (6) For products containing diphenhydramine citrate identified in § 341.12(f). (7) For products containing diphenhydramine hydrochloride identified in § 341.12(g). (8) For products containing doxylamine succinate identified in § 341.12(h). (9) For products containing phenindamine tartrate identified in § 341.12(i). (10) For products containing pheniramine maleate identified in § 341.12(j). (11) For products containing pyrilamine maleate identified in § 341.12(k). (12) For products containing thonzylamine hydrochloride identified in § 341.12(l). (13) For products containing triprolidine hydrochloride identified in § 341.12(m). (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. [57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994; 67 FR 72559, Dec. 6, 2002] § 341.74 Labeling of antitussive drug products. (a) Statement of identity. (b) Indications. (1) “Temporarily” (select one of the following: “alleviates,” “calms,” “controls,” “decreases,” “quiets,” “reduces,” “relieves,” or “suppresses”) “cough due to” (select one of the following: “minor bronchial irritation” or “minor throat and bronchial irritation”) (select one of the following: “as may occur with,” “associated with,” or “occurring with”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.” (2) “Temporarily” (select one of the following: “alleviates,” “calms,” “controls,” “decreases,” “quiets,” “reduces,” “relieves,” or “suppresses”) “cough” (select one of the following: “as may occur with,” “associated with,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants”). (3) In addition to the required information identified in paragraphs (b) (1) and (2) of this section, the labeling of the product may contain any (one or more) of the following statements: (i) “Cough suppressant which temporarily” (select one of the following: “Alleviates,” “controls,” “decreases,” “reduces,” “relieves,” or “suppresses”) “the impulse to cough.” (ii) “Temporarily helps you cough less.” (iii) “Temporarily helps to” (select one of the following: “Alleviate,” “control,” “decrease,” “reduce,” “relieve,” or “suppress”) “the cough reflex that causes coughing.” (iv) “Temporarily” (select one of the following: “Alleviates,” “controls,” “decreases,” “reduces,” “relieves,” or “suppresses”) “the intensity of coughing.” (v) (Select one of the following: “Alleviates,” “Controls,” “Decreases,” “Reduces,” “Relieves,” or “Suppresses”) (select one of the following: “Cough,” “the impulse to cough,” or “your cough”) “to help you” (select one of the following: “Get to sleep,” “sleep,” or “rest”). (vi) For products containing chlophedianol hydrochloride, codeine ingredients, dextromethorphan, or dextromethorphan hydrobromide identified in § 341.14(a) (1), (2), (3), and (4). (vii) For products containing chlophedianol hydrochloride, dextromethorphan, dextromethorphan hydrobromide, camphor, or menthol identified in § 341.14(a) (1), (3), (4) and (b) (1) and (2). a ( b (c) Warnings. (1) For oral and topical antitussives. (2) For oral and topical antitussives labeled for adults or for adults and children under 12 years of age. (3) For oral and topical antitussives labeled only for children under 12 years of age. (4) Oral antitussives For products containing codeine ingredients identified in § 341.14(a)(2). (ii) For products containing codeine ingredients identified in § 341.14(a)(2) when labeled only for adults. (iii) For products containing codeine ingredients identified in § 341.14(a)(2) when labeled only for children under 12 years of age. (iv) For products containing codeine ingredients identified in § 341.14(a)(2) when labeled for use in adults and children under 12 years of age. (v) For products containing dextromethorphan or dextromethorphan hydrobromide as identified in § 341.14 (a)(3) and (a)(4) when labeled for adults or for adults and children under 12 years of age. Drug interaction precaution. (vi) For products containing dextromethorphan or dextromethorphan hydrobromide as identified in § 341.14 (a)(3) and (a)(4) when labeled only for children under 12 years of age. Drug interaction precaution. (vii) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.14 (a)(5) and (a)(6). (viii) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.14 (a)(5) and (a)(6) when labeled only for children under 12 years of age (B) “May cause marked drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.” (C) “Do not use [bullet] 1 1 (ix) For products containing diphenhydramine citrate or diphenhydramine hydrochloride identified in § 341.14 (a)(5) and (a)(6) when labeled for use in adults and children under 12 years of age (B) “May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.” (C) “Do not use [bullet] with any other product containing diphenhydramine, even one used on skin”. (5) Topical antitussives For products containing camphor or menthol identified in § 341.14 (b) (1) and (2) in a suitable ointment vehicle. (ii) For products containing camphor or menthol identified in § 341.14(b) (1) and (2) for steam inhalation use. (iii) For any product containing camphor or menthol in a suitable ointment vehicle or for steam inhalation use and meets the definition of one of the signal words (“extremely flammable,” “flammable,” “combustible”) as described in 16 CFR 1500.3(b)(10). (iv) For any product containing camphor or menthol in a suitable ointment vehicle and that does not contain a flammability signal word as described in 16 CFR 1500.3(b)(10). 1 1 (v) For any product containing camphor or menthol in a suitable ointment vehicle and that contains a flammability signal word as described in 16 CFR 1500.3(b)(10). (vi) For any product containing camphor or menthol for steam inhalation use. (vii) For any product formulated in a volatile vehicle. (d) Directions. (1) Oral antitussives For products containing chlophedianol hydrochloride identified in § 341.14(a)(1). (ii) For products containing codeine ingredients identified in § 341.14(a)(2). (iii) For products containing dextromethorphan or dextromethorphan hydrobromide identified in § 341.14(a) (3) and (4). (iv) For products containing diphenhydramine citrate identified in § 341.14(a)(5). (v) For products containing diphenhydramine hydrochloride identified in § 341.14(a)(6). (2) Topical antitussives For products containing camphor identified in § 341.14(b)(1) in a suitable ointment vehicle. (ii) For products containing menthol identified in § 341.14(b)(2) in a suitable ointment vehicle. (iii) For products containing menthol identified in § 341.14(b)(2) in a lozenge. (iv) For products containing camphor identified in § 341.14(b)(1) for steam inhalation use. For products formulated to be added directly to cold water inside a hot steam vaporizer. 1/2 For products formulated to be placed in the medication chamber of a hot steam vaporizer. (v) For products containing menthol identified in § 341.14(b)(2) for steam inhalation use. For products formulated to be added directly to cold water inside a hot steam vaporizer. 1/2 For products formulated to be placed in the medication chamber of a hot steam vaporizer. (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. (f) Exemption from the general accidental overdose warning. [52 FR 30055, Aug. 12, 1987; 52 FR 35610, Sept. 22, 1987; 53 FR 35809, Sept. 15, 1988; 55 FR 27808, July 6, 1990; 55 FR 40383, Oct. 3, 1990; 58 FR 54236, Oct. 20, 1993; 59 FR 29174, June 3, 1994; 59 FR 36051, July 15, 1994; 64 FR 13295, Mar. 17, 1999; 65 FR 8, Jan. 3, 2000; 65 FR 46867, Aug. 1, 2000; 67 FR 72559, Dec. 6, 2002] § 341.76 Labeling of bronchodilator drug products. (a) Statement of identity. (b) Indication. 1 1 (c) Warnings. (1) The following statements shall appear after the subheading “Do not use” [in bold type]: (i) “[Bullet] unless a doctor said you have asthma”. (ii) “[Bullet] if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.” (2) The following information shall appear after the subheading “Ask a doctor before use if you have” [in bold type]: “[bullet] ever been hospitalized for asthma [bullet] heart disease [bullet] high blood pressure [bullet] diabetes [bullet] thyroid disease [bullet] seizures [bullet] narrow angle glaucoma [bullet] a psychiatric or emotional condition [bullet] trouble urinating due to an enlarged prostate gland”. (3) The following information shall appear after the subheading “Ask a doctor or pharmacist before use if you are” [in bold type]: (i) “[Bullet] taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions”. (ii) “[Bullet] taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)”. (4) The following information shall appear after the subheading “When using this product” [in bold type]: (i) “[Bullet] your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.” [in bold type] (ii) “[Bullet] your risk of heart attack or stroke increases if you: [Bullet] have a history of high blood pressure or heart disease [Bullet] take this product more frequently or take more than the recommended dose”. [in bold type] (iii) “[Bullet] avoid foods or beverages that contain caffeine”. (iv) “[Bullet] avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect”. (5) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16(a), (b), (c), and (f). (A) “[Bullet] are not better in 60 minutes”. (B) “[Bullet] get worse”. (C) “[Bullet] need more than [insert total number of dosage units that equals 150 milligrams] in 24 hours”. (D) “[Bullet] use more than [insert total number of dosage units that equals 100 milligrams] in 24 hours for 3 or more days a week”. (E) “[Bullet] have more than 2 asthma attacks in a week”. (F) “These may be signs that your asthma is getting worse.” (G) “[Bullet] This product will not give you asthma relief as quickly as an inhaled bronchodilator.” (ii) This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings”. (6) For products containing epinephrine, epinephrine bitartrate, or racepinephrine hydrochloride identified in § 341.16(d), (e), and (g). (A) “[Bullet] are not better in 20 minutes”. (B) “[Bullet] get worse”. (C) “[Bullet] need more than 12 inhalations in 24 hours”. (D) “[Bullet] use more than 9 inhalations in 24 hours for 3 or more days a week”. (E) “[Bullet] have more than 2 asthma attacks in a week”. (F) “These may be signs that your asthma is getting worse.” (ii) This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings.” (iii) For products intended for use in a hand-held rubber bulb nebulizer. (7) The following information shall appear after the subheading “Stop use and ask a doctor if” [in bold type]: (i) “[Bullet] your asthma is getting worse (see Asthma alert)”. (ii) “[Bullet] you have difficulty sleeping”. (iii) “[Bullet] you have a rapid heart beat”. (iv) “[Bullet] you have tremors, nervousness, or seizure”. (d) Directions. (1) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16(a), (b), (c), and (f): (ii) “[Bullet] adults and children 12 years of age and over: oral dose is 12.5 to 25 milligrams every 4 hours as needed. Do not take more than 150 milligrams in 24 hours”. (iii) “[Bullet] children under 12 years of age: ask a doctor”. (2) For products containing epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride identified in § 341.16(d), (e), and (g) for use in a hand-held rubber bulb nebulizer. (i) “[Bullet] do not use more than directed” [appears as first bulleted statement under “Directions” and in bold type]. (ii) “[Bullet] adults and children 4 years of age and over: 1 to 3 inhalations not more often than every 3 hours. Do not use more than 12 inhalations in 24 hours. The use of this product by children should be supervised by an adult.” (iii) “[Bullet] children under 4 years of age: ask a doctor”. (Collection of information requirement approved by the Office of Management and Budget under control number 0910-0237) [51 FR 35339, Oct. 2, 1986, as amended at 52 FR 7126, Mar. 9, 1987; 52 FR 7830, Mar. 13, 1987; 53 FR 35810, Sept. 15, 1988; 58 FR 54242, Oct. 20, 1993; 61 FR 25146, May 20, 1996; 62 FR 9684, Mar. 4, 1997; 64 FR 13295, Mar. 17, 1999; 76 FR 44487, July 26, 2011] § 341.78 Labeling of expectorant drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (1) “A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.” (2) For expectorant drug products labeled for adults or for adults and children under 12 years of age. (3) For expectorant drug products labeled only for children under 12 years of age. (d) Directions. (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. [54 FR 8509, Feb. 28, 1989, as amended at 57 FR 29177, June 30, 1992] § 341.80 Labeling of nasal decongestant drug products. (a) Statement of identity. (b) Indications. (1) (Select one of the following: “For the temporary relief of nasal congestion” or “Temporarily relieves nasal congestion”) (which may be followed by any of the following in paragraphs (b)(1) (i), (ii), and (iii) of this section): (i) “due to” (select one of the following: “the common cold” or “a cold”). (ii) “due to” (select one of the following: “hay fever,” “hay fever (allergic rhinitis),” “hay fever or other upper respiratory allergies,” or “hay fever or other upper respiratory allergies (allergic rhinitis)”). (2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any (one or more) of the following statements: (i) (Select one of the following: “For the temporary relief of” or “Temporarily relieves”) (select one of the following: “stuffy nose,” “stopped up nose,” “nasal stuffiness,” or “clogged up nose.”) (ii) (Select one of the following: “Reduces swelling of,” “Decongests,” or “Helps clear”) “nasal passages; shrinks swollen membranes.” (iii) “Temporarily restores freer breathing through the nose.” (iv) “Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.” (v) “Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.” (c) Warnings. (1) Oral nasal decongestants For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for adults. (B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.” (C) “Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.” (D) Drug interaction precaution. (ii) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for children under 12 years of age. (B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.” (C) “Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.” (D) Drug interaction precaution. (iii) For oral nasal decongestant products labeled for both adults and children under 12 years of age. (2) Topical nasal decongestants For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for adults. (B) “This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.” (C) “The use of this container by more than one person may spread infection.” (ii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for adults. (iii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20 (b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for adults. (B) “Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.” (iv) For products containing naphazoline hydrochloride identified in § 341.20(b)(6) at a concentration of 0.05 percent. (v) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for adults. (vi) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for children under 12 years of age. (vii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for children under 12 years of age. (viii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20(b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for children under 12 years of age. (B) “Do not use this product in a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.” (ix) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for children under 12 years of age. (x) For topical nasal decongestant products labeled for both adults and for children under 12 years of age. (d) Directions. (1) Oral nasal decongestants For products containing phenylephrine hydrochloride identified in § 341.20(a)(1). (ii) For products containing pseudoephedrine hydrochloride or pseudoephedrine sulfate identified in § 341.20 (a)(2) and (a)(3). (iii) For products containing phenylephrine bitartrate identified in § 341.20(a)(4). Age 1 Dose 1 Adults and children 12 years of age and over 15.6 milligrams every 4 hours not to exceed 62.4 milligrams in 24 hours Children 6 to under 12 years of age 7.8 milligrams every 4 hours not to exceed 31.2 milligrams in 24 hours Children under 6 years of age Ask a doctor 1 (2) Topical nasal decongestants For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form. (ii) For products containing ephedrine, ephedrine hydrochloride, or ephedrine sulfate identified in § 341.20(b) (2), (3), and (4) Nasal drops or sprays—For a 0.5-percent aqueous solution. (B) Nasal jelly For a 0.5-percent water-based jelly. (iii) For products containing naphazoline hydrochloride identified in § 341.20(b)(6) Nasal drops or sprays 1 For a 0.05-percent aqueous solution. ( 2 For a 0.025-percent aqueous solution. (B) Nasal jelly 1 For a 0.05-percent water-based jelly. ( 2 For a 0.025-percent water-based jelly. (iv) For products containing oxymetazoline hydrochloride identified in § 341.20(b)(7) Nasal drops or sprays 1 For a 0.05-percent aqueous solution. ( 2 A 0.025-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.027 milligrams of oxymetazoline per three drops or three sprays. (B) Nasal jelly—For a 0.05-percent water-based jelly. (v) For products containing phenylephrine hydrochloride identified in § 341.20(b)(8) Nasal drops or sprays 1 For a 1-percent aqueous solution. ( 2 For a 0.5-percent aqueous solution. ( 3 For a 0.25-percent aqueous solution. ( 4 A 0.125-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.135 milligrams of phenylephrine per three drops or three sprays. (B) Nasal jelly 1 For a 1-percent water-based jelly. ( 2 For a 0.5-percent water-based jelly. ( 3 For a 0.25-percent water-based jelly. (vi) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form. (vii) For products containing xylometazoline hydrochloride identified in § 341.20(b)(10) Nasal drops or sprays 1 For a 0.1-percent aqueous solution. ( 2 A 0.05-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.054 milligrams of xylometazoline per three drops or three sprays. (B) Nasal jelly 1 For a 0.1-percent water-based jelly. ( 2 For a 0.05-percent water-based jelly. (viii) Other required statements—For products containing levmetamfetamine or propylhexedrine identified in § 341.20(b)(1) or (b)(9) when used in an inhalant dosage form. (B) “Keep inhaler tightly closed.” [59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 64 FR 13295, Mar. 17, 1999; 65 FR 8, Jan. 3, 2000; 70 FR 58977, Oct. 11, 2005; 71 FR 43362, Aug. 1, 2006] § 341.85 Labeling of permitted combinations of active ingredients. The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. (a) Statement of identity. (1) For permitted combinations identified in § 341.40(a), (c), (f), (g), (l), (m), (n), (o), (q), and (r) containing an analgesic-antipyretic active ingredient. (2) [Reserved] (b) Indications. (1) For permitted combinations containing an analgesic-antipyretic active ingredient identified in § 341.40(a), (c), (f). (g), (l), (m), (n), (o), (q), and (r) when labeled for relief of general cough-cold symptoms and/or the common cold. (ii) The labeling for the cough-cold ingredient(s) may follow a separate bullet(s) or may be combined with the relieves part of the indication in paragraph (b)(1)(i) of this section. (2) For permitted combinations containing an analgesic-antipyretic active ingredient identified in § 341.40(a), (c), (f), (g), (m), (q), and (r) when labeled for relief of hay fever/allergic rhinitis and/or nasal congestion symptoms. (ii) The indication(s) for the cough-cold ingredient(s) consists of the labeling for antihistamines in § 341.72(b)(1) or (b)(2) and/or nasal decongestants in § 341.80(b)(1)(ii), as appropriate, and the labeling for any other cough-cold combination. This labeling may follow a separate bullet(s) or may be combined with the indication in paragraph (b)(2)(i) of this section. (3) For permitted combinations containing an oral analgesic-antipyretic active ingredient identified in § 341.40(a), (c), (f), (g), (m), (q), and (r) when labeled for relief of general cough-cold symptoms and/or the common cold and for relief of hay fever/allergic rhinitis and/or nasal congestion symptoms. (4) For permitted combinations containing an oral anesthetic-analgesic active ingredient identified in § 341.40(k), (s), (t), (z), (aa), and (bb). (5) For permitted combinations containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). (6) For permitted combinations containing levmetamfetamine with aromatics identified in § 341.40(v). (7) Other allowable statements. (c) Warnings. (1) For permitted combinations containing an antitussive and an analgesic-antipyretic identified in § 341.40(f), (g), (l), and (m). (i) For products labeled only for adults. (ii) For products labeled only for children under 12 years of age. (iii) For products labeled for both adults and for children under 12 years of age. (2) For permitted combinations containing an expectorant and an analgesic-antipyretic identified in § 341.40(o). (i) For products labeled only for adults. (ii) For products labeled only for children under 12 years of age. (iii) For products labeled for both adults and for children under 12 years of age. (3) For permitted combinations containing a nasal decongestant and an analgesic-antipyretic identified in § 341.40(c), (g), (m), (n), (q), and (r). (i) For products labeled only for adults. (ii) For products labeled for only children under 12 years of age. (iii) For products labeled for both adults and children under 12 years of age. (4) For permitted combinations containing an antihistamine combined with an oral antitussive. (5) For permitted combinations containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). (6) For permitted combinations containing levmetamfetamine with aromatics identified in § 341.40(v). (d) Directions. (1) For permitted combinations containing an anesthetic/analgesic and/or a demulcent in a liquid dosage form identified in § 341.40(k), (s), (t), (w), (x), (y), (z), (aa), and (bb). (2) For permitted combinations containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). (3) For permitted combinations containing levmetamfetamine with aromatics identified in § 341.40(v). [67 FR 78170, Dec. 23, 2002, as amended at 70 FR 58977, Oct. 11, 2005; 71 FR 43362, Aug. 1, 2006; 88 FR 45066, July 14, 2023] § 341.90 Professional labeling. The labeling of the product provided to health professionals (but not to the general public) may contain the following additional dosage information for products containing the active ingredients identified below: (a) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16 (a), (b), (c), and (f). (b) For products containing chlophedianol hydrochloride identified in 341.14(a)(1). (c) For products containing codeine ingredients identified in § 341.14(a)(2). (2) Parents should be instructed to obtain and use a calibrated measuring device for administering the drug to the child, to use extreme care in measuring the dosage, and not exceed the recommended daily dosage. (3) A dispensing device (such as a dropper calibrated for age or weight) should be dispensed along with the product when it is intended for use in children 2 to under 6 years of age to prevent possible overdose due to improper measuring of the dose. (4) Codeine is not recommended for use in children under 2 years of age. Children under 2 years may be more susceptible to the respiratory depressant effects of codeine, including respiratory arrest, coma, and death. (d) The following labeling indication may be used for products containing guaifenesin identified in § 341.18 when used as a single ingredient product. (e) For products containing brompheniramine maleate identified in § 341.12(a). (f) For products containing chlorcyclizine hydrochloride identified in § 341.12(b). (g) For products containing chlorpheniramine maleate identified in § 341.12(c). (h) For products containing dexbrompheniramine maleate identified in § 341.12(d). (i) For products containing dexchlorpheniramine maleate identified in § 341.12(e). (j) For products containing diphenhydramine citrate identified in § 341.12(f). (k) For products containing diphenhydramine hydrochloride identified in § 341.12(g). (l) For products containing doxylamine succinate identified in § 341.12(h). (m) For products containing phenindamine tartrate identified in § 341.12(i). (n) For products containing pheniramine maleate identified in § 341.12(j). (o) For products containing pyrilamine maleate identified in § 341.12(k). (p) For products containing thonzylamine hydrochloride identified in § 341.12(l). (q) For products containing triprolidine hydrochloride identified in § 341.12(m). (r) For products containing diphenhydramine citrate identified in § 341.14(a)(5). (s) For products containing diphenhydramine hydrochloride identified in § 341.14(a)(6). [51 FR 35339, Oct. 2, 1986, as amended at 52 FR 30057, Aug. 12, 1987; 54 FR 8509, Feb. 28, 1989; 57 FR 58376, Dec. 9, 1992; 59 FR 4218, Jan. 28, 1994; 59 FR 29174, June 3, 1994; 59 FR 36051, July 15, 1994]