CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable 
Wal-Mart Stores, Inc.

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Equate

Cetirizine Hydrochloride Chewable Tablets 10 mg

Active Ingredient in each chewable tablet

Cetirizine Hydrochloride Chewable Tablets 10mg

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 doctor if

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

If pregnant or breast-feeding

Keep out of the reach of children

In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

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

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor

QUESTIONS

1-888-287-1915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blister
carton
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-652
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
POLACRILIN (UNII: RCZ785HI7S)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize10mm
FlavorTUTTI FRUTTIImprint Code n;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-652-244 in 1 CARTON03/08/2016
1NDC:49035-652-256 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20679303/08/2016
Labeler - Wal-Mart Stores, Inc. (051957769)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIBusiness Operations
Novel Laboratories, Inc.793518643ANALYSIS(49035-652) , MANUFACTURE(49035-652) , PACK(49035-652)

Revised: 12/2018
Document Id: f5eb545f-57f8-42f5-b9d9-ee3b14661444
Set id: fcc77bdc-5fcc-43c1-be0d-1827eebccf35
Version: 1
Effective Time: 20181221
 
Wal-Mart Stores, Inc.