CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Dispensing Solutions, Inc.

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Drug Facts

Active ingredient

(in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

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 reactions 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 a Poison Control Center right away.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years and over
One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other information

  • Store between 20 to 25 C (68 to 77 F)

Inactive ingredients

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

Principal Display Panel


NDC 66336-0336-XX

NDC 66336-0336-XX

NDC 66336-0336-14


Cetirizine HCl Tablets

10 mg

antihistamine

Tablets.

ALLERGY

Indoor and Outdoor Allergies

24 hour Relief of

    * Sneezing
    * Runny Nose
    * Itchy, Watery Eyes
    * Itchy Throat or Nose

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66336-336(NDC:0781-1684)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLs (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUND (round shape) Size8mm
FlavorImprint Code SZ;906
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66336-336-1414 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07794612/27/2007
Labeler - Dispensing Solutions, Inc. (066070785)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785relabel(66336-336) , repack(66336-336)

Revised: 9/2012
Document Id: 64486ca9-85d5-40d1-9a5b-01d52521ed7b
Set id: dd37b7c4-00d6-4a69-8213-713db5725e7c
Version: 3
Effective Time: 20120927
 
Dispensing Solutions, Inc.