Label: LORATADINE- loratadine tablet

  • NDC Code(s): 51079-246-01, 51079-246-20
  • Packager: Mylan Institutional Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 8, 2016

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

  •    

    Original Prescription Strength Non-Drowsy*

    Indoor and Outdoor Allergies

    *When taken as directed. See Drug Facts Panel.

    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 NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
    protect from excessive moisture
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  • Inactive Ingredients

    Corn starch, lactose monohydrate and magnesium stearate.

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

    Made in India

    Code No.: MH/DRUGS/25/NKD/89

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    S-11333 R2
    11/16

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  •      

    PRINCIPAL DISPLAY PANEL – 10 mg

    NDC 51079-246-20

    Loratadine
    Tablets, USP
    10 mg

    Antihistamine

    Original Prescription Strength    Non-Drowsy*

    Indoor and Outdoor Allergies

    24 Hour Relief (See Uses section of enclosed leaflet)

    *When taken as directed. See enclosed leaflet.

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

    Loratadine Tablets, USP 10 mg Carton Label
    Outer Carton Label
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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51079-246
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code G;L;10
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51079-246-20 100 in 1 BOX, UNIT-DOSE 04/30/2013
    1 NDC:51079-246-01 1 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 ANDA076154 04/30/2013
    Labeler - Mylan Institutional Inc. (039615992)
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