CHILDRENS ALLERGY RELIEF- loratadine solution 
Supervalu Inc

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Childrens allergy relief syrup

Drug Facts

Active ingredient (in each 5 mL)

Loratadine 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.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

If pregnant or breast-feeding, 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.

Directions

adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

PRINCIPAL DISPLAY PANEL - 120mL Bottle Carton

equaline®

compare to
Claritin®

active ingredient*

original
prescription strength

ages
2 years
and
older

children's
allergy
relief syrup
loratadine oral solution
5 mg/5 mL antihistamine

24 hour
non-drowsy
allergy relief

relief of:

When taken as directed.
See Drug Facts Panel.

fruit flavored
syrup

4 FL OZ
(120mL)

PRINCIPAL DISPLAY PANEL - 120mL Bottle Carton
CHILDRENS ALLERGY RELIEF 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-426
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-426-851 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Supervalu Inc (006961411)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(41163-426)

Revised: 10/2012
Document Id: b3ac6c07-a06e-43eb-83ed-379a8a0ce200
Set id: 4669af7a-200c-4931-bfee-796ba4195944
Version: 1
Effective Time: 20121023
 
Supervalu Inc