Label: LORATADINE ANTIHISTAMINE- loratadine tablet

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

Drug Label Information

Updated 06/15

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.

    (1-800-222-1222)

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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 between 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

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  • Questions or comments?

    Questions? 1-800-719-9260

    Generic Section

    Antihistamine 24 Hour

    Indoor & Outdoor Allergies

    Non-Drowsy*

    *When taken as directed. See Drug Facts Panel.

    Original Prescription Strength

    Compare to Claritin® active ingredient

    PERRIGO®

    Distributed BY

    PERRIGO®

    ALLEGAN, MI 49010

    www.perrigo.com

    IT49413400215

    Cardinal Health

    Zanesville, OH 43701

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  • Principal Display Panel

    Loratadine 10 mg

    tablets

    card label
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  • Principal Display Panel

    Loratadine 10 mg

    tablets

    QTY 30

    lidding label
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  • Principal Display Panel

    Loratadine 10 mg

    tablets

    card label
    Close
  • Principal Display Panel

    Loratadine 10 mg

    tablets

    QTY 28

    lidding label
    Close
  • INGREDIENTS AND APPEARANCE
    LORATADINE  ANTIHISTAMINE
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1954(NDC:45802-650)
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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:55154-1954-9 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:55154-1954-3 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076301 10/15/2008
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-1954)
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