CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF - 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


relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings


Severe Allergy Warning
 
Get emergency help immediately if you have hives along with any of the following symptoms: 
 
  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

  • to prevent hives from any known cause such as:  
    • foods                   
    • insect stings
    • medicines                
    • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.  
 
  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 under 6 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 65862-443-12
Children's                           
Cetirizine Hydrochloride
1 mg/mL Oral Solution
antihistamine                           HIVES
                                                 Relief
24 hour      
Relief of
ITCHING
6 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 65862-443-12
Children's
Cetirizine Hydrochloride
1 mg/mL Oral Solution
antihistamine                  HIVES
                                         Relief
24 hour
Relief of  
ITCHING
6 yrs.
& older
Grape
Syrup
120 mL
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)
CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65862-443
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:65862-443-121 in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:65862-443-48480 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: 2f736e99-637a-476b-a107-cb97bdbb8c38
Set id: 2f736e99-637a-476b-a107-cb97bdbb8c38
Version: 1
Effective Time: 20100208
 
Aurobindo Pharma Limited