[Code of Federal Regulations] [Title 21 Volume 5] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR341.40] [Page 230-233] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents Subpart C--Labeling Sec. 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 Secs. 341.70 or 341.85: (a) Any single antihistamine active ingredient identified in Sec. 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 Sec. 341.85. (b) Any single antihistamine active ingredient identified in Sec. 341.12 may be combined with any single oral nasal decongestant active ingredient identified in Sec. 341.20(a) provided that the product is labeled according to Sec. 341.85. (c) Any single antihistamine active ingredient identified in Sec. 341.12 may be combined with any single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 341.85. (d) Any single antihistamine active ingredient identified in Sec. 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in Sec. 341.14(a)(1) through (a)(4) provided that the product is labeled according to Sec. 341.85(c)(4). Diphenhydramine citrate in Secs. 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in Secs. 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 Sec. 341.70(a). (e) Any single antihistamine active ingredient identified in Sec. 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in Sec. 341.14(a)(1) through (a)(4) and any single oral nasal decongestant active ingredient identified in Sec. 341.20(a) provided that the product is labeled according to Sec. 341.85(c)(4). Diphenhydramine citrate in Secs. 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in Secs. 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 Sec. 341.70(a). (f) Any single antihistamine active ingredient identified in Sec. 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in Sec. 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 Sec. 341.85(c)(4). Diphenhydramine citrate in Secs. 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in Secs. 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 Sec. 341.70(a). (g) Any single antihistamine active ingredient identified in Sec. 341.12(a) through (e) and (h) through (m) may be combined with any single oral antitussive active ingredient identified in Sec. 341.14(a)(1) through (a)(4) and any [[Page 231]] single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 341.85(c)(4). Diphenhydramine citrate in Secs. 341.12(f) and 341.14(a)(5) or diphenhydramine hydrochloride in Secs. 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 Sec. 341.70(a). (h) Any single oral antitussive active ingredient identified in Sec. 341.14(a)(1) through (a)(4) may be combined with any single expectorant active ingredient identified in Sec. 341.18 provided that the product is labeled according to Sec. 341.85. (i) Any single oral antitussive active ingredient identified in Sec. 341.14(a) may be combined with any single oral nasal decongestant active ingredient identified in Sec. 341.20(a) provided that the product is labeled according to Sec. 341.85. (j) Any single oral antitussive active ingredient identified in Sec. 341.14(a)(1) through (a)(4) may be combined with any single oral nasal decongestant active ingredient identified in Sec. 341.20(a) and any single expectorant active ingredient identified in Sec. 341.18 provided that the product is labeled according to Sec. 341.85. (k) Any single antitussive active ingredient identified in Sec. 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 Sec. 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 Sec. 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 Sec. 341.70(b). (l) Any single oral antitussive active ingredient identified in Sec. 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 Sec. 341.85. (m) Any single oral antitussive active ingredient identified in Sec. 341.14(a) may be combined with any single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 341.85. (n) Any single oral antitussive active ingredient identified in Sec. 341.14(a)(1) through (a)(4) may be combined with any single oral nasal decongestant active ingredient identified in Sec. 341.20(a) and any single expectorant active ingredient identified in Sec. 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 Sec. 341.85. (o) Any single expectorant active ingredient identified in Sec. 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 Sec. 341.85. (p) Any single expectorant active ingredient identified in Sec. 341.18 may be combined with any single oral nasal decongestant active ingredient identified in Sec. 341.20(a) provided that the product is labeled according to Sec. 341.85. (q) Any single expectorant active ingredient identified in Sec. 341.18 may be [[Page 232]] combined with any single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 341.85. (r) Any single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 341.85. (s) Any single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 341.85. (t) Any single oral nasal decongestant active ingredient identified in Sec. 341.20(a) may be combined with any single antitussive active ingredient identified in Sec. 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 Sec. 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 Sec. 341.14(b)(1) may be combined with menthol identified in Sec. 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 Sec. 341.85. (v) Levmetamfetamine identified in Sec. 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 Sec. 341.85. (w) Any single antitussive active ingredient identified in Sec. 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 Sec. 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 Sec. 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 Sec. 341.85. (y) Any single antitussive active ingredient identified in Sec. 341.14(a) or (b)(2) may be combined with any single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 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 Sec. 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 [[Page 233]] 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 Sec. 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 Sec. 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 Sec. 341.85. (bb) Any single antitussive active ingredient identified in Sec. 341.14(a) or (b)(2) may be combined with any single oral nasal decongestant active ingredient identified in Sec. 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 Sec. 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] Effective Date Note: At 67 FR 78168, Dec. 23, 2002, Sec. 341.40 was added, effective Dec. 23, 2004.