[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: 21CFR341.12]

[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.  341.12  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]