CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY - cetirizine hydrochloride solution 
Aurohealth LLC

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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:


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


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

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


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


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


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


2 yrs.& older
Cherry Flavor 
Dye-Free
4 fl oz (120 mL) Dosing Cup Included
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:58602-028
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID (UNII: Q40Q9N063P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorYELLOW (Colorless to Pale Yellow) Score    
ShapeSize
FlavorCHERRY (Cherry Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-028-241 in 1 CARTON06/24/2015
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:58602-028-201 in 1 CARTON06/24/2015
2240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
3NDC:58602-028-26480 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/24/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09075006/24/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-028) , MANUFACTURE(58602-028)

Revised: 11/2022
Document Id: 56e4d904-4c1b-4af3-b96f-b0cb70ad8d17
Set id: 4de4f544-79cd-4a89-aafb-f2e2688b3c81
Version: 4
Effective Time: 20221103
 
Aurohealth LLC