Label: LORATADINE tablet

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

Drug Label Information

Updated January 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Loratadine 10 mg

  • Purpose

    Antihistamine

  • Uses

    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

    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.

  • 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
  • Other information

    • safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
    • store between 2°C and 30°C (36°F and 86°F)
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

  • HOW SUPPLIED

    Product: 50090-0838

    NDC: 50090-0838-0 10 TABLET in a BOTTLE

    NDC: 50090-0838-1 20 TABLET in a BOTTLE

    NDC: 50090-0838-3 15 TABLET in a BOTTLE

    NDC: 50090-0838-4 30 TABLET in a BOTTLE

    NDC: 50090-0838-5 90 TABLET in a BOTTLE

    NDC: 50090-0838-6 7 TABLET in a BOTTLE

  • Questions or comments?

    Call 1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time

    Manufactured by:Manufactured for:
    Apotex Inc.Apotex Corp.
    Toronto, OntarioWeston, Florida
    Canada M9L 1T933326

    Revised: August 2018

  • Loratadine

    Label Image
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0838(NDC:60505-0147)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code LOR;10;APO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0838-590 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    2NDC:50090-0838-120 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    3NDC:50090-0838-315 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    4NDC:50090-0838-67 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    5NDC:50090-0838-010 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    6NDC:50090-0838-430 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07647101/24/2005
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0838) , REPACK(50090-0838)
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