
USFDA APPLICATION NUMBER - 20786 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| FEXOFENADINE(UNII: E6582LOH6V) (FEXOFENADINE - UNII:E6582LOH6V) | FEXOFENADINE | 60mg |
| PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) | PSEUDOEPHEDRINE | 60mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | bryant ranch prepack | Chattem, Inc. | Physicians Total Care, Inc. | sanofi-aventis U.S. LLC | McKESSON Corporation | Target Brands Inc. |
|---|---|---|---|---|---|---|---|
| carnauba wax(R12CBM0EIZ) | |||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||
| HYDROXYPROPYL CELLULOSE (200000 MW)(5Y0974F5PW) | |||||||
| HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI) | |||||||
| HYPROMELLOSE(3NXW29V3WO) | |||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||
| MANNITOL(3OWL53L36A) | |||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||||
| POLYETHYLENE GLYCOL 6000(30IQX730WE) | |||||||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | |||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||
| POWDERED CELLULOSE(SMD1X3XO9M) | |||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||
| STARCH, CORN(O8232NY3SJ) | |||||||
| STARCH, PREGELATINIZED CORN(O8232NY3SJ) | |||||||
| STEARIC ACID(4ELV7Z65AP) | |||||||
| TRIETHYL CITRATE(8Z96QXD6UM) |