CHILDRENS ALLERGY RELIEF - cetirizine hydrochloride solution 
Strategic Sourcing Services

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ACTIVE INGREDIENT(S)

(in each 5 mL)
Cetirizine Hydrochloride USP 5mg


PURPOSE

Antihistamine

USE(S)

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   833-358-6431
                                              
Distributed by:
McKesson Corp.,
via Strategic Sourcing Services, LLC.,
Memphis TN 38141


PRINCIPAL DISPLAY PANEL


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


cetirizinehclos-contlabel


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

carton-cetirizineos


CHILDRENS ALLERGY RELIEF  
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0149
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:70677-0149-11 in 1 CARTON07/21/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21062207/21/2022
Labeler - Strategic Sourcing Services (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Hetero Labs Limited Unit III676162024manufacture(70677-0149)

Revised: 7/2022
Document Id: e4c85780-7cb5-b55c-e053-2995a90a0314
Set id: 1dd63ede-37ca-4b5a-bfed-1aca5dd15424
Version: 1
Effective Time: 20220727
 
Strategic Sourcing Services