[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: 21CFR338.10]

[Page 226]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 338--NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart B--Active Ingredients
 
Sec. 338.10  Nighttime sleep-aid active ingredients.


    The active ingredient of the product consists of any of the 
following when used within the dosage limits established for each 
ingredient in Sec. 338.50(d):
    (a) Diphenhydramine hydrochloride.
    (b) Diphenhydramine citrate.