Label: LORATADINE  ANTIHISTAMINE- loratadine tablet 

  • Label RSS
  • 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 10/09

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

  • Active ingredient (in each tablet)

    Loratadine 10 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
    • sneezing
    • itchy, watery eyes
    • 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.

    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 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

    • do not use if printed foil under cap is broken or missing
    • store at 20°-25°C (68°-77°F)
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  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

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  • Questions or comments?

    1-800-719-9260

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  • LORATADINE ANTIHISTAMINE (LORATADINE) TABLET
  • INGREDIENTS AND APPEARANCE
    LORATADINE   ANTIHISTAMINE
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50436-3502(NDC:45802-650)
    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
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POVIDONES  
    STARCH, CORN  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 8mm
    Flavor Imprint Code L612
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50436-3502-1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076301 10/15/2008
    Labeler - Unit Dose Services (831995316)
    Registrant - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK(50436-3502)
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