21 C.F.R. Subpart B—Active Ingredients
Title 21 - Food and Drugs
Title 21: Food and Drugs
PART 343—INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 343.10 [Reserved]
§ 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.
§ 343.13 Rheumatologic 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.
§ 343.20 [Reserved]
§ 343.22 Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
Combinations containing aspirin must meet the standards of an acceptable dissolution test, as set forth in §343.90. The following combinations are permitted: Aspirin identified in §§343.12 and 343.13 may be combined with any antacid ingredient identified in §331.11 of this chapter or any combination of antacids permitted in accordance with §331.10(a) of this chapter provided that the finished product meets the requirements of §331.10 of this chapter and is marketed in a form intended for ingestion as a solution.
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