Label: LORATADINE- loratadine tablet 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL 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 (LORATADINE) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    STARCH, CORN  
    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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