[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: 21CFR338.10]

[Page 234]
 
                        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--
 
                      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.