Label: LORATADINEANTIHISTAMINE ANTIHISTAMINE- loratadine tablet

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

Drug Label Information

Updated May 20, 2013

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  • OTC - ACTIVE INGREDIENT

    Loratadine 10 mg

     

  • OTC - PURPOSE

    Antihistamine

     

  • INDICATIONS & USAGE

    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

     

  • WARNINGS

    if you have ever had an allergic reaction to this product or any of its ingredients

     

    liver or kidney disease. Your doctor should determine if you need a different dose.

     

    do not take more than directed. Taking more than directed may cause drowsiness.

     

    an allergic reaction to this product occurs. Seek medical help right away.

     

    ask a health professional before use.

     

    In case of overdose, get medical help or contact a Poison Control Center right away.

     

  • DOSAGE & ADMINISTRATION

    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

     

  • STORAGE AND HANDLING

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

     

  • INACTIVE INGREDIENT

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

     

  • OTC - QUESTIONS

    1-800-719-9260

     

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

    DRUG: Loratadineantihistamine antihistamine


    GENERIC: Loratadine


    DOSAGE: TABLET


    ADMINSTRATION: ORAL


    NDC: 49349-218-20


    ACTIVE INGREDIENT(S):

    • LORATADINE 10mg in 1


    INACTIVE INGREDIENT(S):

    • LACTOSE MONOHYDRATE
    • POVIDONE
    • MAGNESIUM STEARATE
    • STARCH, CORN


    COLOR: white


    SHAPE: OVAL


    SCORE: No score


    SIZE: 8 mm


    IMPRINT: L612


    PACKAGING: 100 in 1 VIAL



    MM1

    MM2

  • INGREDIENTS AND APPEARANCE
    LORATADINEANTIHISTAMINE  ANTIHISTAMINE
    loratadine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49349-218(NDC:45802-650)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (TABLET) Size8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49349-218-20100 in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630105/20/2013
    Labeler - REMEDYREPACK INC. (829572556)
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