EQUATE  CHILDRENS ALLERGY RELIEF- loratadine solution 
Wal-Mart Stores Inc

----------

equate®
Children's 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.

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

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.

Questions?

1-888-287-1915

Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 49035-092-08

equate®

Compare
to Children's
Claritin
®
Active
Ingredient*

Sugar Free

Ages 2+

Children's
Allergy Relief
Loratadine Oral Solution
5 mg/5 mL Antihistamine

24 Hour
Non-Drowsy**

Relieves:
• Sneezing • Runny nose
• Itchy, watery eyes
• Itchy throat or nose

Original
Prescription
Strength

Dosage cup
enclosed

Indoor and
Outdoor Allergies

Dye Free Grape Flavor

4 FL OZ (120 mL)

**When taken as directed
See Drug Facts Panel

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
EQUATE   CHILDRENS ALLERGY RELIEF
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-092
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
glycerin (UNII: PDC6A3C0OX)  
sorbitol (UNII: 506T60A25R)  
phosphoric acid (UNII: E4GA8884NN)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-092-081 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49035-092)

Revised: 1/2013
Document Id: b12e1df6-1da9-4d77-9862-667dbc1030f6
Set id: faae4d8e-1d33-4236-b380-7b2884c08812
Version: 1
Effective Time: 20130103
 
Wal-Mart Stores Inc