CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Unique Pharmaceutical Laboratories

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Cetirizine Hydrochloride Tablets, 5 mg, Allergy

Active Ingredients

Active Ingredients (in each tablet)                                                        Purpose
Cetirizine HCl 5 mg.....................................................................................Antihistimine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Warnings

Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

Adults and children 6
 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65 years and over1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours.
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor

Other Information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-866-562-4597

Manufactured for Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.

Cetirizine Hydrochloride Tablets 5 mg Container Label

NDC 16571-401-10

Original Prescription Strength

Cetirizine Hydrochloride

Tablets 5 mg

Antihistamine 24 Hour Relief of:

100 Tablets

Allergy

Indoor & Outdoor

Allergies

PACK PHARMACEUTICALS LLC

Container Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67668-161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
hypromellose (UNII: 3NXW29V3WO)  
lactose (UNII: J2B2A4N98G)  
magnesium stearate (UNII: 70097M6I30)  
starch, corn (UNII: O8232NY3SJ)  
polyethylene glycol (UNII: 3WJQ0SDW1A)  
povidone (UNII: FZ989GH94E)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint Code CTN;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67668-161-3030 in 1 BOTTLE
2NDC:67668-161-4545 in 1 BOTTLE
3NDC:67668-161-00100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Unique Pharmaceutical Laboratories (917165052)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645MANUFACTURE, analysis

Revised: 12/2009
Document Id: 89050554-8e16-41ce-88a5-30718b7f6f9c
Set id: 139536a1-b021-4ef3-902f-b618da5aaa44
Version: 2
Effective Time: 20091218
 
Unique Pharmaceutical Laboratories