GroundRules
21 CFR 343.22: Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 343—INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—Active Ingredients
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON