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USFDA APPLICATION NUMBER - 88616 / DOSAGE - TABLET;ORAL - 325MG;50MG;40MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) | ACETAMINOPHEN | 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 | Avera McKennan Hospital | AvPAK | Bryant Ranch Prepack | Cardinal Health | Golden State Medical Supply, Inc. | Hikma Pharmaceuticals USA Inc. | KAISER FOUNDATION HOSPITALS | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | Mikart, LLC | Mirror Pharmaceuticals LLC | NuCare Pharmaceuticals, Inc. | PD-Rx Pharmaceuticals, Inc. | REMEDYREPACK INC. | West-ward Pharmaceutical Corp | Alvogen Inc. | KVK-Tech, Inc. | Major Pharmaceuticals |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||||||
| Colloidal Silicon Dioxide(ETJ7Z6XBU4) | |||||||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||||||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | |||||||||||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |||||||||||||||||||
| CROSPOVIDONE(2S7830E561) | |||||||||||||||||||
| CROSPOVIDONE(68401960MK) | |||||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||||||
| HYDROGENATED COTTONSEED OIL(Z82Y2C65EA) | |||||||||||||||||||
| ISOSTEARIC ACID(X33R8U0062) | |||||||||||||||||||
| Magnesium Stearate(70097M6I30) | |||||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||||||
| POVIDONE(FZ989GH94E) | |||||||||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||||||||||
| POVIDONES(FZ989GH94E) | |||||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||||||||
| STARCH, PREGELATINIZED CORN(O8232NY3SJ) | |||||||||||||||||||
| STEARIC ACID(4ELV7Z65AP) | |||||||||||||||||||
| TALC(7SEV7J4R1U) |
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