Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 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.

source: 63 FR 56814, Oct. 23, 1998, unless otherwise noted.
cite as: 21 CFR 343.12