Your browser does not support JavaScript! WAL-ITIN ALLERGY RELIEF (LORATADINE) SOLUTION [WALGREEN COMPANY]
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WAL-ITIN ALLERGY RELIEF (loratadine) solution
[Walgreen Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

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 over		2 teaspoonfuls daily; do not take
more than 2 teaspoonfuls in 24 hours
children 2 to under
6 years of age		1 teaspoonful daily; do not take more
than 1 teaspoonful in 24 hours
consumers with liver
or kidney disease		ask a doctor

Other information

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)

Inactive ingredients

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

Distributed by: Walgreen Co.,
200 Wilmot Rd., Deerfield, IL 60015-4616

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Compare to Children's
Claritin†® active ingredient

NDC 0363-2085-08

Walgreens

Ages 2 Years
& Older

24 HOUR
ALLERGY RELIEF

Children's Non-Drowsy*
WAL-ITIN®

Loratadine Oral Solution,
5mg/5mL Antihistamine

Allergy Relief
Alcohol-Free

Relief of:

  • Sneezing • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Dye-Free

Original Prescription Strength

GRAPE
FLAVORED SYRUP

4 FL OZ (120 mL)

* When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
WAL-ITIN ALLERGY RELIEF 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2085
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
glycerin 
propylene glycol 
water 
sodium benzoate 
sodium metabisulfite 
sucrose 
Product Characteristics
ColorYELLOW (Colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-2085-081 in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:0363-2085-011 in 1 CARTON
2240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Walgreen Company (008965063)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Indutries Ltd.600072078MANUFACTURE(0363-2085)

Revised: 01/2013
Document Id: baec871b-0e97-42ca-88c7-83220512f588
Set id: bb7392d6-77b9-42d3-82d2-8b21715774c8
Version: 2
Effective Time: 20130122
 
Walgreen Company

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