ALLERGY RELIEF  CHILDRENS- loratadine solution 
H E B

----------

Allergy Relief
Children's

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.

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. (1-800-222-1222)

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 ageask a doctor
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

Questions?

Call 1-866-923-4914

DISTRIBUTED BY H-E-B, SAN ANTONIO, TX 78204

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Compare to Children's Claritin®
active ingredient*

H-E-B®

ALLERGY RELIEF

Children's

Loratadine Oral Solution
5 mg/5 mL (Antihistamine)

24 Hour Non-Drowsy†
Allergy Relief

For Ages 2 & Over

Grape Flavor

† When taken as directed.
See Drug Facts Panel.

4 FL OZ (120 mL)

Principal Display Panel - 120 mL Bottle Carton
ALLERGY RELIEF   CHILDRENS
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-085
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:37808-085-081 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - H E B (007924756)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(37808-085)

Revised: 11/2012
Document Id: 05953fc3-e0c3-4257-a0cd-cc89ca69fc3c
Set id: e46e0ccf-ad09-45e7-9d36-909f9b4cd710
Version: 1
Effective Time: 20121108
 
H E B