Label: QUALITY CHOICE CHILDRENS ALLERGY RELIEF- loratadine solution

  • NDC Code(s): 63868-156-04
  • Packager: Chain Drug Marketing Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/12

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5 mL)

    Loratadine 5 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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.

    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.

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  • 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
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  • 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)
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  • Inactive ingredients

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

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  • Questions?

    call 1-800-935-2362

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY QUALITY CHOICE 43157 WEST NINE MILE ROAD
    NOVI, MI 48376-0995

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Compare to the
    active ingredient in
    Claritin®

    QC
    QUALITY
    CHOICE®

    NDC 63868-156-04

    NON-DROWSY*

    Children's
    ALLERGY
    RELIEF

    (Loratadine
    Oral Solution)
    5 mg/5 mL
    Antihistamine

    Ages two years
    and older

    24 Hour
    Allergy Relief

    Relief of:
    Sneezing; Runny Nose,
    Itchy, Watery Eyes,
    Itchy Throat or Nose

    Grape Flavored
    Syrup

    4 FL OZ
    (118 mL)

    *When taken as directed. See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE   CHILDRENS ALLERGY RELIEF
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-156
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color YELLOW (colorless to slightly yellow) Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-156-04 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076805 08/20/2004
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(63868-156)
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