CHILDRENS ALLERGY RELIEF - cetirizine hydrochloride solution 
Fred's, Inc.

----------

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

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

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
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
1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 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)

Inactive ingredients

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions?

call 1-855-274-4122

Distributed by:
Fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com


fred’s Promise Not Happy With This Product? Just Bring It Back For a Refund!


PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)

NDC 55315-354-31

fred*s
KIDS®
2 yrs & older

Children's
Allergy
Relief

Indoor & Outdoor
Allergies

Cetirizine Hydrochloride
Oral Solution, USP 1mg/mL
Antihistamine
Grape Flavored Syrup

24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Dosing Cup
Included

4
FL OZ (120 mL)
Compare to
*Children's ZYRTEC®
PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)

CHILDRENS ALLERGY RELIEF 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-354
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
FlavorBANANA, GRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-354-311 in 1 CARTON01/31/2015
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09075001/31/2015
Labeler - Fred's, Inc. (005866116)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642MANUFACTURE(55315-354)

Revised: 12/2020
Document Id: 17d2db07-4de0-4e02-8e2e-0082c275faab
Set id: 55e799b2-e325-4286-aa9a-b88e99ab1146
Version: 5
Effective Time: 20201213
 
Fred's, Inc.