Label: CLARITIN- loratadine tablet

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

Drug Label Information

Updated October 12, 2023

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  • CLARITIN ®

    Active ingredients (in each tablet)

    Purpose

    Loratadine 10 mg

    Antihistamine

  • USE

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

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

    If pregnant or breast-feeding, ask 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 age ask a doctor
     consumer with liver or kidney disease ask a doctor

  • Other information

    • Safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn
    • Store between 20 o to 25 o C (68 o to 77 o F)
    • Protect from excessive moisture
  • Inactive ingredients

    Coen starch, lactose monohydrate, magnesium stearate

  • Questions and Comments?

    1-800-CLARITIN(1-800-252-7484) or www.claritin.com

    Dist. by: Bayer HealthCare LLC

    Whippany, NJ 07981

    Product of Ireland

    Do not use if pouch is torn or broken.

    Repackaged and distributed by:

    RJ General

    2024 Northwest Drive

    Cincinnati OH 45231

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL - 25 Tablet Pouch Carton

    Non-Drowsy*

    Claritin ®

    loratadine tablets 10 mg/ antihistamine

    Indoor & Outdoor Allergies

    Relief of:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the throat or nose 

    image description

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70264-030(NDC:11523-6655)
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70264-030-0125 in 1 CARTON12/26/2022
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965803/01/2021
    Labeler - R J General Corporation (122542830)
    Establishment
    NameAddressID/FEIBusiness Operations
    R J General Corporation122542830repack(70264-030)
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