Label: LORATADINE tablet

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

Drug Label Information

Updated March 30, 2022

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  • ACTIVE INGREDIENT

    Loratadine 10mg

  • PURPOSE

    Antihistamine

  • 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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Adults and children 6 years and over 1 tablet daily: no 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

  • SAFE HANDLING WARNING

    Other Information ● store between 20-25°C (68-77°F) ● protect from excessive moisture ● do not use if imprinted seal under safety cap is broken or missing

  • INACTIVE INGREDIENT

    Inactive Ingredients lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

  • PRINCIPAL DISPLAY PANEL

    Display Panel

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73629-003-18180 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072203/30/2022
    Labeler - AMZ789 LLC (117410213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutra-Med Packaging Inc.022004902pack(73629-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(73629-003)
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