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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 | Chattem, Inc. | 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 K25-31(D9C330MD8B) | ||||
| copovidone(D9C330MD8B) | ||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||
| HYDROGENATED COTTONSEED OIL(Z82Y2C65EA) | ||||
| HYPROMELLOSE(3NXW29V3WO) | ||||
| HYPROMELLOSES(3NXW29V3WO) | ||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| METHYL ALCOHOL(Y4S76JWI15) | ||||
| methylene chloride(588X2YUY0A) | ||||
| polyethylene glycol(3WJQ0SDW1A) | ||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
| povidone(FZ989GH94E) | ||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||
| silicon dioxide(ETJ7Z6XBU4) | ||||
| sodium chloride(451W47IQ8X) | ||||
| sodium stearyl fumarate(7CV7WJK4UI) | ||||
| talc(7SEV7J4R1U) | ||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||
| TRIACETIN(XHX3C3X673) | ||||
| water(059QF0KO0R) |
