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USFDA APPLICATION NUMBER - 20232 / DOSAGE - CAPSULE;ORAL - 325MG;50MG;40MG;30MG
| 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 |
| CODEINE PHOSPHATE(UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) | CODEINE PHOSPHATE | 30mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions LLC | Actavis Pharma, Inc. | Allergan, Inc. | West-Ward Pharmaceuticals Corp | Breckenridge Pharmaceutical, Inc. | Bryant Ranch Prepack | Mayne Pharma Inc. | A-S Medication Solutions | Par Pharmaceutical, Inc. |
|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||
| D&C Red No. 28(767IP0Y5NH) | |||||||||
| D&C RED NO. 33(9DBA0SBB0L) | |||||||||
| D&C RED NO. 7(ECW0LZ41X8) | |||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||
| FD&C Blue No. 1(H3R47K3TBD) | |||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | |||||||||
| FD&C Red No. 40(WZB9127XOA) | |||||||||
| FD&C Yellow No. 5(I753WB2F1M) | |||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||
| Ferrosoferric Oxide(XM0M87F357) | |||||||||
| GELATIN(2G86QN327L) | |||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||
| silicon dioxide(ETJ7Z6XBU4) | |||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||
| stearic acid(4ELV7Z65AP) | |||||||||
| TALC(7SEV7J4R1U) | |||||||||
| Titanium Dioxide(15FIX9V2JP) |
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