• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2019]
[CITE: 21CFR341.40]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 341 -- COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

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 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]

-
-