Label: LORATADINE- loratadine tablet

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

Drug Label Information

Updated 10/12

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

  • Active ingredient

    Loratidine USP 10 mg

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  • Purpose

    Antihistamine

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  • Use

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies, runny nose, itchy, watery eyes, sneezing, itching of the nose and throat.

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  • Warning

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

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  • Ask a doctor before use if you have

    liver or kidney disease. You doctor should determine if you need a different dose.

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  • Ask a doctor or pharmacist before use if you are
  • When using this product

    do not take more than directed. Taking more than directed may cause drowsiness.

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  • Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

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  • Pregnancy/breast-feeding warning

    Ask a health professional before use.

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  • 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 and over:    1 tablet daily not more than 1 tablet in 24 hours

    Children under 6 years of age:     ask a doctor

    Consumers with liver or kidney disease:    ask a doctor

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  • Other information

    Store at 20º - 25ºC (68º -77ºF); excursions permitted to 15o - 30o C (59o - 86o F). [ See USP Controlled Room Temperature]

    Protect from excessive moisture.

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  • Inactive ingredients

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch.

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  • Questions?

    Questions or comments? (800) 616-2471

    Distributed by:

    MAJOR® PHARMACEUTICALS

    31778 Enterprise Drive, Livonia, MI  48150 USA

    Re-Order No. 301592

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  • PRINCIPAL DISPLAY PANEL LORATADINE TABLETS, USP 10MG

     LORATADINE TABLETS, USP 10MG

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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6074(NDC:51660-526)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code rx526
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6074-61 100 in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076134 06/15/2010
    Labeler - Major Pharmaceuticals (191427277)
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