Label: CLARITIN- loratadine tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 10, 2019

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  • 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

    ● safety sealed: do not use if the individual blister unit imprinted with Claritin ® 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 or Comments?

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

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-005(NDC:11523-7160)
    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;Claritin10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73097-005-011 in 1 CARTON07/03/2019
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73097-005-2020 in 1 CARTON07/03/2019
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:73097-005-2525 in 1 CARTON07/03/2019
    31 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01965807/03/2019
    Labeler - Savings Distributors LLC (010527359)
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