21 CFR § 343.12 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use

§ 343.12 Cardiovascular active ingredients.

Current through Sep 8, 2026 · Read all of Part 343

(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.

← § 343.10 [Reserved]§ 343.13 Rheumatologic active ingredients. →