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 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 LABEL 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 (LORATADINE) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    SILICON DIOXIDE  
    STARCH, CORN  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    SODIUM LAURYL SULFATE  
    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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