CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
Padagis Israel Pharmaceuticals Ltd

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Perrigo Children's Cetirizine Hydrochloride Oral Solution 1 mg/mL 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

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children's Zyrtec® active ingredient

Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL

Antihistamine

Allergy

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

2 yrs & older

Dye-Free

Grape Syrup

4 FL OZ (118 mL)

Indoor & Outdoor Allergies

Perrigo Children's Cetirizine image
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-974
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
ACETIC ACID (UNII: Q40Q9N063P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorYELLOW (Pale Yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-974-261 in 1 CARTON04/15/2008
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09025404/15/2008
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021
Document Id: 4ab6acdb-a469-4da0-9127-c75b5be16131
Set id: c2cf555d-986c-4e89-ac4f-938e92c418e2
Version: 4
Effective Time: 20211111
 
Padagis Israel Pharmaceuticals Ltd