CHILDRENS ALLERGY RELIEF- loratadine solution 
Rite Aid Corporation

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Childrens Allergy Relief

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

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 (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
children 2 to under 6 years of age1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
children under 2 years of age ask a doctor
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:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

RITE
AID®
PHARMACY

Compare to the
active ingredient in
Children's Claritin®*

ORIGINAL
PRESCRIPTION
STRENGTH

children's
allergy
relief

loratadine oral solution
5 mg/5 mL antihistamine

fruit flavored oral solution

INDOOR &
OUTDOOR ALLERGIES

NON-DROWSY

DYE FREE

24 hour relief of:

sneezing & runny nose
itchy, watery eyes
itchy throat or nose

2 years & older

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS ALLERGY RELIEF 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0098
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
FlavorFRUIT (peach) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0098-31 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Rite Aid Corporation (014578892)
Registrant - Taro Pharmacceuticals U.S.A., Inc (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(11822-0098)

Revised: 10/2012
Document Id: 3687f442-6f1b-4144-996b-fff76dd17230
Set id: 42582848-38a4-41e9-adb4-cdb14ccd3f3a
Version: 1
Effective Time: 20121018
 
Rite Aid Corporation