Levocetirizine Dihydrochloride

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DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 2.5MG/5ML, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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USFDA APPLICATION NUMBER - 22157 / DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
levocetirizine dihydrochloride(UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)	levocetirizine dihydrochloride	0.5mg in 1 \| 5mg

Inactive Ingredients

Ingredient Name	Sanofi-Aventis U.S. LLC	UCB, Inc.	Winthrop U.S.
.alpha.-tocopherol, dl-(7QWA1RIO01)
acetic acid(Q40Q9N063P)
cellulose, microcrystalline(OP1R32D61U)
FD&C Red No. 40(WZB9127XOA)
glycerin(PDC6A3C0OX)
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)

Drug Product Composition: Levocetirizine Dihydrochloride