§343.22. Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
21 C.F.R. § 343.22
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 63 FR 56814, Oct. 23, 1998, unless otherwise noted.