CHILDRENS ALLERGY RELIEF- cetirizine hcl tablet, chewable
Wal-Mart Stores Inc

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Equate 44-578

Active ingredient (in each chewable 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
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 enter (1-800-222-1222) right away.

Directions

may be taken with or without water

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

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store between 20º-25ºC (68º-77ºF)
see end flap for expiration date and lot number

Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc, tutti frutti flavor

Questions?

1-888-287-1915

Principal display panel

equate®

NDC 49035-578-02

Compare
to Children's
Zyrtec® Allergy
Active
Ingredient*

Ages 6+
Children's
Allergy Relief

Cetirizine HCl Chewables 10 mg
Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:
• Sneezing • Runny nose
• Itchy, watery eyes • Itchy throat or nose

Fruit Flavor

10
mg

12
TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

Satisfaction guaranteed -
Or we'll replace it or give
you your money back.
For questions or
comments or to report
an undesired reaction or
side effect, please call
1-888-287-1915.

*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark
Children's Zyrtec® Allergy.

Product of India 50844 ORG031357802

Equate 44-578

CHILDRENS ALLERGY RELIEF
cetirizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-578
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETADEX (UNII: JV039JZZ3A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK (peach color)	Score	no score
Shape	ROUND	Size	10mm
Flavor	TUTTI FRUTTI	Imprint Code	SZ;106
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-578-02	2 in 1 CARTON	10/31/2008	09/11/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078692	10/31/2008	09/11/2020

Labeler - Wal-Mart Stores Inc (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(49035-578)

Revised: 11/2017

Document Id: c2615957-3095-46a0-8db4-3b98293c92f5

Set id: c67082d0-8524-42b0-bec8-af683363b999

Version: 6

Effective Time: 20171113

Wal-Mart Stores Inc