CHILDRENS CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, orally disintegrating

CHILDRENS CETIRIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

CHILDRENS CETIRIZINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by WALMART INC., Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 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 (1-800-222-1222) right away.

Directions

Tablet melts in mouth. Can 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

• store between 20° to 25°C (68° to 77°F). Avoid high humidity.
• do not use if blister unit is torn or broken

Inactive ingredients

betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate, sucralose.

Questions or comments?
call 1-888-287-1915

 

DISTRIBUTED BY:

Walmart Inc., Bentonville, AR 72716

PRODUCT OF INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton

ORIGINAL PRESCRIPTION STRENGTH

equateTM

NDC: 79903-406-10

Compare to
Children's
Zyrtec®
Allergy active
Ingredient*

children's

ALLERGY RELIEF
Cetirizine Hydrochloride Orally
Disintegrating Tablets, USP 10 mg
Antihistamine

Sugar-Free    Dye-Free

6 YEARS AND OLDER

Indoor & Outdoor Allergies
Melts in your mouth                Actual
Orange Flavor                         Size

Dissolve Tabs

24 Hour Relief of

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat or nose

24 orally disintegrating tablets 10 mg each

INGREDIENTS AND APPEARANCE

CHILDRENS CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-406
Route of Administration	ORAL

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
BETADEX (UNII: JV039JZZ3A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor	ORANGE	Imprint Code	CE;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-406-10	4 in 1 CARTON	01/14/2026
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213557	01/14/2026

Labeler - WALMART INC. (051957769)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(79903-406) , MANUFACTURE(79903-406)