CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY - cetirizine hydrochloride solution 
Aurobindo Pharma Limited

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Drug Facts

Active ingredient (in each 5 mL teaspoonful)


Cetirizine hydrochloride 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.

Directions

  • use only with enclosed dosing cup

   adults and children 6 years and over
  1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once
  daily depending upon severity of symptoms; do not take
  more than 2 teaspoonfuls (10 mL) in 24 hours.
   adults 65 years and over
  1 teaspoonful (5 mL) once daily; do not take more
  than 1 teaspoonful (5 mL) in 24 hours.
   children 2 to under 6 years of age
  ½ tea spoonful (2.5 mL) once daily. If needed, dose
  can be increased to a maximum of 1 teaspoonful (5 mL) 
  once daily or ½ tea spoonful (2.5 mL) every 12 hours.
  Do not give more than 1 teaspoonful (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)

Inactive ingredients


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

Questions?


call 1-866-850-2876

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)


NDC 65862-422-12
Children's
Cetirizine Hydrochloride
1 mg/mL Oral Solution
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of
  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 yrs.
& older
Grape
Syrup
120 mL
AUROBINDO
 
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)


NDC 65862-422-12
Children's
Cetirizine Hydrochloride
1 mg/mL Oral Solution
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of
  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 yrs.
& older
Grape
Syrup
Dosing Cup
Included
120 mL
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)
CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65862-422
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 
SUCROSE 
Product Characteristics
ColorYELLOW (Colorless to Pale Yellow) Score    
ShapeSize
FlavorBANANA, GRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65862-422-121 in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:65862-422-48480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09075002/02/2010
Labeler - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642MANUFACTURE

Revised: 02/2010
Document Id: ecbc32c3-6979-49e1-85bd-159065687e54
Set id: ecbc32c3-6979-49e1-85bd-159065687e54
Version: 1
Effective Time: 20100208
 
Aurobindo Pharma Limited