USFDA APPLICATION NUMBER - 22064 / DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
levocetirizine dihydrochloride(UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O) | levocetirizine dihydrochloride | 5mg |
Inactive Ingredients
Ingredient Name | Sanofi-Aventis U.S. LLC | UCB, Inc. | Winthrop U.S. | Lake Erie Medical DBA Quality Care Products LLC | UCB Farchim S.A. | Valeant Pharmaceuticals International Inc. |
---|---|---|---|---|---|---|
.alpha.-tocopherol, dl-(7QWA1RIO01) | ||||||
acetic acid(Q40Q9N063P) | ||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||
FD&C Red No. 40(WZB9127XOA) | ||||||
glycerin(PDC6A3C0OX) | ||||||
hypromellose(3NXW29V3WO) | ||||||
hypromellose, unspecified(3NXW29V3WO) | ||||||
hypromelloses(3NXW29V3WO) | ||||||
lactose monohydrate(EWQ57Q8I5X) | ||||||
magnesium stearate(70097M6I30) | ||||||
maltitol(D65DG142WK) | ||||||
methylparaben(A2I8C7HI9T) | ||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||
polyethylene glycol 400(B697894SGQ) | ||||||
propylparaben(Z8IX2SC1OH) | ||||||
saccharin(FST467XS7D) | ||||||
shellac(46N107B71O) | ||||||
silicon dioxide(ETJ7Z6XBU4) | ||||||
sodium acetate(4550K0SC9B) | ||||||
titanium dioxide(15FIX9V2JP) | ||||||
triacetin(XHX3C3X673) | ||||||
water(059QF0KO0R) |
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