[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341.14]

[Page 237]
 
                        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 
 
                      Subpart B_Active Ingredients
 
Sec.  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 Sec.  341.74(d):
    (a) Oral antitussives. (1) Chlophedianol hydrochloride.
    (2) Codeine ingredients. The following ingredients may be used only 
in combination in accordance with Sec. Sec.  290.2 and 21 CFR 
1308.15(c).
    (i) Codeine.
    (ii) Codeine phosphate.
    (iii) Codeine sulfate.
    (3) Dextromethorphan.
    (4) Dextromethorphan hydrobromide.
    (5) Diphenhydramine citrate.
    (6) Diphenhydramine hydrochloride.
    (b) Topical antitussives. (1) Camphor.
    (2) Menthol.

[52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 
FR 4907, Feb. 1, 2002]