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USFDA APPLICATION NUMBER - 86162 / DOSAGE - TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ASPIRIN(UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) | ASPIRIN | 325mg |
| BUTALBITAL(UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK) | BUTALBITAL | 50mg |
| CAFFEINE(UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) | CAFFEINE | 40mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions LLC | Actavis Pharma, Inc. | Allergan, Inc. | American Health Packaging | Bryant Ranch Prepack | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | West-ward Pharmaceutical Corp | A-S Medication Solutions | Major Pharmaceuticals |
|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||
| FD&C GREEN NO. 3(3P3ONR6O1S) | ||||||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||||||
| GELATIN(2G86QN327L) | ||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||||
| HYDROGENATED COTTONSEED OIL(Z82Y2C65EA) | ||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||
| TALC(7SEV7J4R1U) |
