XYZAL- levocetirizine dihydrochloride tablet 
Valeant Pharmaceuticals International Inc.

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XYZAL®

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label

90 tablets

XYZAL®
(levocetirizine
dihydrochloride)

5 mg per tablet
For oral administration

ucb

Rx Only

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label
XYZAL 
levocetirizine dihydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64734-920
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Levocetirizine Dihydrochloride (UNII: SOD6A38AGA) (Levocetirizine - UNII:6U5EA9RT2O) Levocetirizine Dihydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
lactose monohydrate (UNII: EWQ57Q8I5X)  
magnesium stearate (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
titanium dioxide (UNII: 15FIX9V2JP)  
polyethylene glycol 400 (UNII: B697894SGQ)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVAL (film coated) Size8mm
FlavorImprint Code Y
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64734-920-9090 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02206408/09/2007
Labeler - Valeant Pharmaceuticals International Inc. (245141858)
Establishment
NameAddressID/FEIBusiness Operations
Valeant Pharmaceuticals International Inc.245141858MANUFACTURE(64734-920) , PACK(64734-920) , ANALYSIS(64734-920) , LABEL(64734-920)

Revised: 3/2018
Document Id: 10e9cc6e-b0e9-47e7-a74a-b5e78ed5ddd3
Set id: a89fdb5c-ba50-4fed-a8a2-9da1ae34844f
Version: 2
Effective Time: 20180316
 
Valeant Pharmaceuticals International Inc.