CHILDRENS NON-DROWSY  24-HOUR ALLERGY RELIEF- loratadine solution 
Safeway Inc.

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Children's Non-Drowsy*
24-Hour Allergy Relief

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.

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

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99, PLEASANTON, CA 94566-0009

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 21130-787-29

Compare to
Children's Claritin®
active ingredient

Children's
Non-Drowsy*

24-Hour
Allergy Relief

Loratadine Oral Solution
5 mg/5 mL
Antihistamine

Relieves:

Ages two years and older

*When taken as directed.
See Drug Facts panel.

Dosage cup enclosed
Dye-Free

Grape Flavored
Alcohol Free

4 FL OZ
(120 mL)

SAFEWAY

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS NON-DROWSY   24-HOUR ALLERGY RELIEF
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-787
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
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-787-291 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Safeway Inc. (009137209)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(21130-787)

Revised: 10/2012
Document Id: b55db1a4-f78b-48aa-8a9d-fce56def3d10
Set id: 2053418b-a76b-4ec4-8fbe-9898ecba4502
Version: 1
Effective Time: 20121030
 
Safeway Inc.