Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 0067-6122-30
  • Packager: Novartsi Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 1, 2009

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  • Active ingredient

    loratadine 10mg

  • Purpose

    antihistamine

  • 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

  • Warnings

  • Do Not Use

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

  • Ask Doctor

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

  • When Using

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

  • Stop Use

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • Pregnancy or Breast Feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Overdose

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

  • Other Information

    • safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only)
    • safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only)
    • store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)
  • Directions

    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
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions

    call 1-800-452-0051

     

     Distributed by DOLGENCORP, LLC

    100 Mission Ridge

    Goodlettsville, TN 37072

  • Principal Display

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    Dollar General

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code GG;296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-6122-303 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA07520901/11/2010
    Labeler - Novartsi Consumer Health, Inc. (879821635)
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