21 C.F.R. § 343.12

Cardiovascular active ingredients.

Last amended: 2016Year: 2026Length: 59 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 343.12 (2026)

(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.
Cross-references to the CFR
331.11
21 C.F.R. § 343.12: Cardiovascular active ingredients. | Justis AI