[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: 21CFR343.13]

[Page 252]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 343--INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart B--Active Ingredients
 
Sec. 343.13  Rheumatologic active ingredients.

    (a) Aspirin.
    (b) Buffered aspirin. Aspirin identified in paragraph (a) of this 
section may be buffered with any antacid ingredient(s) identified in 
Sec. 331.11 of this chapter provided that the finished product contains 
at least 1.9 milliequivalents of acid-neutralizing capacity per 325 
milligrams of aspirin as measured by the procedure provided in the 
United States Pharmacopeia 23/National Formulary 18.