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Childrens Allergy Relief by Shopko Stores Operating Co., LLC

Medically reviewed on Jun 18, 2018

Dosage form: solution
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg in 5mL
Labeler: Shopko Stores Operating Co., LLC
NDC Code: 37012-475

Shopko Children’s Allergy Relief Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 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. (1-800-222-1222)

Directions
use only with enclosed dosing cup
find right dose on chart below
mL = milliliter

adults and children 6 years and over

5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.

adults 65 years and over

5 mL once daily; do not take more than 5 mL in 24 hours.

children 2 to under 6 years of age

2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.

children under 2 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)
do not use if carton is opened, or if printed neckband is broken or missing
see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Children’s Zyrtec® active ingredient

2 YEARS AND OLDER

CHILDREN’S

ALLERGY RELIEF

Cetirizine Hydrochloride Oral Solution 1 mg/mL

ANTIHISTAMINE

Indoor & Outdoor Allergies

24-Hour Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Dye-Free

Sugar-Free

GRAPE FLAVORED

Dosing Cup Included

4 FL OZ (118 mL)

CHILDRENS ALLERGY RELIEF 
cetirizine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-475
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37012-475-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20422603/22/2016
Labeler - Shopko Stores Operating Co., LLC (023252638)

 
Shopko Stores Operating Co., LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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