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Cetirizine Hydrochloride by Taro Pharmaceuticals U.S.A., Inc.

Medically reviewed on Jan 22, 2018

Dosage form: solution
Ingredients: Cetirizine Hydrochloride 1mg in 1mL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2106

Children's Cetirizine Hydrochloride Oral Solution

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 over5 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 over5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age2.5 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 ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information
  • do not use if carton is opened or if imprinted safety seal is broken or missing
  • see bottom panel for lot number and expiration date
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

Questions?

Call 1-866-923-4914

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Compare to the
active ingredient
in Children's Zyrtec
®*

NDC 51672-2106-8

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

Antihistamine

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 Yrs. & older

Bubble Gum
Flavor

Dosing Cup Included

4 FL OZ
(120 mL)

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
acetic acid 
glycerin 
methylparaben 
propylene glycol 
propylparaben 
water 
sodium acetate anhydrous 
sucralose 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51672-2106-81 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:51672-2106-11 BOTTLE in 1 CARTON
2240 mL in 1 BOTTLE
3NDC:51672-2106-41 BOTTLE in 1 CARTON
360 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20154605/20/2011
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceutical Industries, Ltd.600072078MANUFACTURE(51672-2106)

 
Taro Pharmaceuticals U.S.A., Inc.

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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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