ALL DAY ALLERGY ANTIHISTAMINE- cetirizine hcl tablet 
P and L Development of New York Corporation

----------

Cetirizine Hydrochloride Tablets

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:

● runny nose

● sneezing

● itchy, watery eyes

● itching of the nose or throat

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

● drowsiness may occur

● avoid alcoholic drinks

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use.

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 overTake 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 overask 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

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide.

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9am-5pm EST.

Principal Display Panel

†Compare to the active ingredient in Zyrtec®

24 Hour

All Day Allergy

Cetirizine HCl Tablets, 10 mg

Antihistamine

Allergy Relief of:

Treats Indoor & Outdoor allergies

†This product is not manufactured or distributed by McNeil Consumer Healthcare Division of McNeil-PPC, Inc., owner of the registered trademark Zyrtec®

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

Westbury, NY 11590

PRODUCT OF INDIA

Product Label

PL Developments

Cetirizine HCl 10 mg tablets

ALL DAY ALLERGY  ANTIHISTAMINE
cetirizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-220
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code W989
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-220-141 in 1 CARTON
114 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07842712/05/2012
Labeler - P and L Development of New York Corporation (800014821)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: eb44a8b3-be84-4e0f-8e4a-14b928b347c8
Set id: 43e2621d-624f-4249-be54-e093367dab01
Version: 1
Effective Time: 20121220
 
P and L Development of New York Corporation