Childrens Cetirizine Hydrochloride Hives Relief

Aurobindo Pharma Limited

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Active ingredient (in each 5 mL teaspoonful)
  • Purpose
• Childrens Cetirizine Hydrochloride Hives Relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding:
  • Keep out of reach of children.
• Directions
• Childrens Cetirizine Hydrochloride Hives Relief Other information
• Inactive ingredients
• Questions?
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Purpose

Childrens Cetirizine Hydrochloride Hives Relief Uses

Warnings

• trouble swallowing
• dizziness or loss of consciousness
• swelling of tongue
• swelling in or around mouth
• trouble speaking
• drooling
• wheezing or problems breathing

Do not use

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

• 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

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.

Directions

• use only with enclosed dosing cup

Childrens Cetirizine Hydrochloride Hives Relief Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Questions?

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

Children's
Cetirizine Hydrochloride
Oral Solution USP 
1 mg/mL
antihistamine                           HIVES 
                                                 Relief
24 hour      
Relief of
ITCHING
6 yrs.
& older
Grape
Syrup
4 fl oz (120 mL)
AUROBINDO

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

Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  HIVES
                                        Relief
24 hour
Relief of  
ITCHING
6 yrs.
& older
Grape
Syrup
4 fl oz (120 mL)
AUROBINDO

Childrens Cetirizine Hydrochloride Hives Relief Cetirizine Hydrochloride SOLUTION Product Information Product Type Human otc drug label Item Code (Source) NDC:65862-443 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE CETIRIZINE 1 mg Inactive Ingredients Ingredient Name Strength ACETIC ACID GLYCERIN METHYLPARABEN propylene glycol PROPYLPARABEN water SODIUM ACETATE SUCROSE Product Characteristics Color YELLOW (Colorless to Pale Yellow) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 120 in 1 BOTTLE 2 240 in 1 BOTTLE 3 NDC:65862-443-48 480 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090750 2010-02-02