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Notes

§343.12. Cardiovascular active ingredients.

21 C.F.R. § 343.12

(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.
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.