
USFDA APPLICATION NUMBER - 21704 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| fexofenadine hydrochloride(UNII: 2S068B75ZU) (Fexofenadine - UNII:E6582LOH6V) | fexofenadine hydrochloride | 180mg |
| pseudoephedrine hydrochloride(UNII: 6V9V2RYJ8N) (pseudoephedrine - UNII:7CUC9DDI9F) | pseudoephedrine hydrochloride | 240mg |
Inactive Ingredients
| Ingredient Name | sanofi-aventis U.S. LLC | STAT RX USA LLC | Dr.Reddy's Laboratories Limited |
|---|---|---|---|
| ACETONE(1364PS73AF) | |||
| acetyltributyl citrate(0ZBX0N59RZ) | |||
| aluminum oxide(LMI26O6933) | |||
| cellulose acetate(3J2P07GVB6) | |||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||
| colloidal silicon dioxide(ETJ7Z6XBU4) | |||
| copovidone(D9C330MD8B) | |||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | |||
| FD&C Blue No. 1(H3R47K3TBD) | |||
| HYDROGENATED COTTONSEED OIL(Z82Y2C65EA) | |||
| HYPROMELLOSE(3NXW29V3WO) | |||
| HYPROMELLOSES(3NXW29V3WO) | |||
| ISOPROPYL ALCOHOL(ND2M416302) | |||
| magnesium stearate(70097M6I30) | |||
| methyl alcohol(Y4S76JWI15) | |||
| methylene chloride(588X2YUY0A) | |||
| polyethylene glycol(3WJQ0SDW1A) | |||
| povidone(FZ989GH94E) | |||
| silicon dioxide(ETJ7Z6XBU4) | |||
| SODIUM CHLORIDE(451W47IQ8X) | |||
| sodium stearyl fumarate(7CV7WJK4UI) | |||
| talc(7SEV7J4R1U) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||
| water(059QF0KO0R) |