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Childrens Cetirizine Hydrochloride Allergy

Medically reviewed on Sep 3, 2018

Dosage form: solution
Ingredients: CETIRIZINE HYDROCHLORIDE 1mg in 1mL
Labeler: Aurohealth LLC
NDC Code: 58602-028

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine hydrochloride USP 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
  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 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (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)
  • Do not use if carton is opened, or if cap safety seal is broken or missing.

Inactive ingredients

cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose

Questions?

call 1-855-274-4122

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is opened, or if cap safety seal is broken or missing.

Manufactured for:
AUROHEALTH LLC,
2572 Brunswick Pike,
Lawrenceville, NJ 08648

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

M.L.No.: 19/HD/AP/95/F/R

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

AUROHEALTH

NDC 58602-028-24

Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

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

2 yrs.& older
Cherry Flavor
Dye-Free
 
4 fl oz (120 mL)




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

AUROHEALTH

NDC 58602-028-24

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

antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

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

2 yrs.& older
Cherry Flavor 
Dye-Free
4 fl oz (120 mL) Dosing Cup Included



CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-028
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
FlavorCHERRY (Cherry Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-028-241 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:58602-028-201 BOTTLE in 1 CARTON
2240 mL in 1 BOTTLE
3NDC:58602-028-26480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09075006/24/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited918917642ANALYSIS(58602-028), MANUFACTURE(58602-028)

 
Aurohealth LLC

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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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