ALL DAY ALLERGY RELIEF- cetirizine hydrochloride tablet 
ASSURED (Greenbrier International, Inc.)

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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 over  Take 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

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®

All Day

Allergy Relief

Cetirizine Hydrochloride tablets, 10 mg

Antihistamine

Relief of:

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.

PRODUCT OF INDIA

Package Labeling

Assured

Cetirizine HCl 10 mg

ALL DAY ALLERGY RELIEF 
cetirizine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0128
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code W989
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-0128-4 1 in 1 CARTON
1 14 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078427 10/19/2012
Labeler - ASSURED (Greenbrier International, Inc.) (610322518)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 7a6d1cc4-509b-4941-b1e7-6017a4f516bf
Set id: 36737f78-2220-40ea-9dd5-c9f737bcdb07
Version: 1
Effective Time: 20121221
 
ASSURED (Greenbrier International, Inc.)