CHILDRENS ALLERGY RELIEF - cetirizine hydrochloride solution 
Camber Consumer Care Inc

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Active ingredient

(in each 5 mL)
Cetirizine Hydrochloride USP 5mg


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

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding


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

anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

Questions?

call 1-888-588-1418
                                              
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.


PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-container label


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Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-carton label


cetirizinehcloscarton

CHILDRENS ALLERGY RELIEF  
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-316
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Coloryellow (Colorless to Yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-316-111 in 1 CARTON03/13/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21062203/13/2019
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Hetero Labs Limited Unit III676162024manufacture(69230-316)
Establishment
NameAddressID/FEIBusiness Operations
Annora Pharma Private Limited650980746manufacture(69230-316)

Revised: 3/2024
Document Id: 14a303ce-ffb0-acd3-e063-6294a90a9327
Set id: 941e4aa9-6388-424c-87ad-3ea2ec5aafea
Version: 2
Effective Time: 20240327
 
Camber Consumer Care Inc