StacksVerified U.S. regulatory reference

21 CFR §343.12

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Aspirin.
  2. (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.