WAL-ITIN ALLERGY RELIEF (LORATADINE) SOLUTION [WALGREEN COMPANY]

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WAL-ITIN ALLERGY RELIEF (LORATADINE) SOLUTION [WALGREEN COMPANY]
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NDC 0363-2085-01, 0363-2085-08
Set ID bb7392d6-77b9-42d3-82d2-8b21715774c8
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA076805
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  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    WAL-ITIN ALLERGY RELIEF 
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2085
    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: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)
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