CAREONE CHILDRENS ALLERGY RELIEF- cetirizine hcl solution 
American Sales Company

----------

American Sales Company 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 the active ingredient in Children’s Zyrtec®

For Ages 2 Years and Older

SUGAR FREE

Children’s Allergy Relief

Cetirizine Hydrochloride Oral Solution 1mg/mL

Antihistamine

dosing cup included

Grape Flavored

24hr

24-HOUR RELIEF OF:

Sneezing – Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor Allergies

Dye Free

Gluten Free

OUR PHARMACISTS RECOMMEND

4 FL OZ (118mL)

children's allergy relief image

CAREONE CHILDRENS ALLERGY RELIEF 
cetirizine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-902
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-902-261 in 1 CARTON06/23/2016
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41520-902-341 in 1 CARTON06/23/2016
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20422606/23/2016
Labeler - American Sales Company (809183973)

Revised: 12/2018
Document Id: d2628e81-5c0b-4b38-a92e-39452159202a
Set id: 0582736b-e129-4048-967c-6270c776f9db
Version: 3
Effective Time: 20181214
 
American Sales Company