Collapse to view only § 343.13 - Rheumatologic active ingredients.
- § 343.10 - [Reserved]
- § 343.12 - Cardiovascular active ingredients.
- § 343.13 - Rheumatologic active ingredients.
- § 343.20 - [Reserved]
- § 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
§ 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.