[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341.40]

[Page 238-241]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 341_COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart B_Active Ingredients
 
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 Sec. Sec. 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

[[Page 239]]

in Sec. Sec. 341.12(f) and 341.14(a)(5) or diphenhydramine 
hydrochloride in Sec. Sec. 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 Sec. Sec. 341.12(f) and 341.14(a)(5) or diphenhydramine 
hydrochloride in Sec. Sec. 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 Sec. Sec. 341.12(f) and 341.14(a)(5) or diphenhydramine 
hydrochloride in Sec. Sec. 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 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 Sec. Sec. 341.12(f) and 341.14(a)(5) or 
diphenhydramine hydrochloride in Sec. Sec. 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

[[Page 240]]

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 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)

[[Page 241]]

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 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]