21 C.F.R. § 343.12

Current through May 31, 2024
Section 343.12 - Cardiovascular 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 § 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.

21 C.F.R. §343.12