Label: CLARITIN- loratadine tablet

  • NDC Code(s): 11523-6655-1, 11523-6655-2, 11523-6655-3, 11523-6655-4, view more
    11523-6655-5, 11523-6655-6, 11523-6655-7, 11523-6655-8, 11523-6655-9
  • Packager: Bayer HealthCare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 13, 2022

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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
    • 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 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 over: 1 tablet daily; not 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

  • Other information (Bottles)

    • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
    • store between 20° to 25°C (68° to 77°F)

    Other information (Blister foil units)

    • safety sealed: do not use if the individual blister unit imprinted with Claritin (R) is open or torn
    • store between 20° to 25° C (68° to 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate

  • Questions of comments?

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

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

    Original Prescription

    Strength

    Non-Drowsy*

    Claritin     ®

    loratadine tablets 10 mg/antihistamine

    24 Hour

    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    Indoor & Outdoor

    Allergies

    *When taken as directed.

    See Drug Facts Panel.

    70 TABLETS

    Window box carton 70 count

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 458;Claritin;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-6655-11 in 1 POUCH04/12/1993
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-6655-21 in 1 CARTON04/12/1993
    270 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:11523-6655-32 in 1 BLISTER PACK04/12/1993
    345 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:11523-6655-41 in 1 BLISTER PACK04/12/1993
    4105 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:11523-6655-61 in 1 BLISTER PACK04/12/1993
    5105 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:11523-6655-725 in 1 BOX04/12/1993
    61 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:11523-6655-91 in 1 CARTON04/12/1993
    780 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:11523-6655-81 in 1 CARTON04/12/1993
    830 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:11523-6655-51 in 1 CARTON04/12/1993
    960 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965804/12/1993
    Labeler - Bayer HealthCare LLC (112117283)
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