Label: LORATADINE- loratadine tablet

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

Drug Label Information

Updated 03/13

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

  • SPL UNCLASSIFIED SECTION

    Original Prescription Strength
    Non-Drowsy

    Indoor and Outdoor Allergies

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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  • Active ingredient (in each tablet)

    Loratadine USP, 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
    • 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.

    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 (24 Hour Relief)

    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

    • TAMPER EVIDENT: DO NOTUSE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
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  • Inactive ingredients

    Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

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  • Questions or comments?

    1-800-848-0462

    • Serious side effects associated with use of this product may be reported to this number.

    Manufactured by:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Distributed by:
    UDL Laboratories, Inc.
    Rockford, IL 61103

    S-10314 R1
    7/11

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  • Principal Display Panel

    Loratadine Tablets, USP

    10 mg

    Antihistamine

    10 Tablets

    bag label
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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-5099(NDC:51079-538)
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code M;L;17
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-5099-0 10 in 1 BAG
    1 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075790 11/19/2009
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-5099)
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