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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NUMBER - 22064 / DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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