Label: LORATADINE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 9, 2011

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  • Active ingredient

    Loratadine USP, 10 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing

  • 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 thsi 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.

  • Directions

    adults and children 6 years and over 1 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
  • Other Information

    store between 20 and 25°C (68 and 77°F) · protect from excessive moisture.

  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • Questions?

    call 1-800-406-7984

    †This product is not manufactured or distributed by Schering-Plough Healthcare Products Inc., owner of the registered trademark Claritin®.

    Manufactured by
    Ohm Laboratories, Inc.
    North Brunswick, NJ 08902

    Repackaged by
    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Principal Display Panel

    Loratadine 10mg

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-499(NDC:51660-526)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code RX;526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-499-1515 in 1 BOTTLE
    2NDC:21695-499-2020 in 1 BOTTLE
    3NDC:21695-499-3030 in 1 BOTTLE
    4NDC:21695-499-9090 in 1 BOTTLE
    5NDC:21695-499-72120 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/21/2010
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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