Label: CHILDRENS LORATADINE- loratadine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • 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. 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.

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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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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

    Repackaged By:
    Aidarex Pharmaceuticals, LLC.
    Corona, CA 92880

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  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC 33261-908-01

    Compare to the
    active ingredient
    in Claritin®*

    GRAPE
    FLAVOR

    Original
    Prescription Strength

    Ages two years and older

    Children's
    Loratadine
    Syrup
    (Loratadine
    Oral Solution)
    5 mg/5 mL
    Antihistamine

    Grape Flavored Syrup

    24 hour
    Non-Drowsy

    Allergy Relief

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

    4 FL OZ (120 mL)

    When taken as directed. See Drug Facts Panel.

    Image Label
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE 
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-908(NDC:51672-2085)
    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:33261-908-01 5 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 - Aidarex Pharmaceuticals LLC (801503249)
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