§343.12. Cardiovascular active ingredients.
21 C.F.R. § 343.12
Aspirin.
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 63 FR 56814, Oct. 23, 1998, unless otherwise noted.