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) |
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