Label: LORATADINE ODT- loratadine tablet, orally disintegrating

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

Drug Label Information

Updated 04/12

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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine USP, 10 mg

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  • PURPOSE

    Antihistamine

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  • 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
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  • 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 (1-800-222-1222).

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  • DIRECTIONS

    • place 1 tablet on tongue; tablet disintegrates, with or without water
      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
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  • OTHER INFORMATION

    • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
    • keep in a dry place.
    • use tablet immediately after opening individual blister.
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  • INACTIVE INGREDIENTS

    Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

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  • QUESTIONS?

    call 1-888-423-0139

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  • PRINCIPAL DISPLAY PANEL

    Topcare®

    NDC 36800-528-69

    Ages 6 years and older

    Children's MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED

    Original Prescription Strength

    24 HOUR NON-DROWSY*

    Allergy Relief

    LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg

    ANTIHISTAMINE

    Indoor & Outdoor Allergies

    For 24 Hour Relief of:

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

    COMPARE TO CLARITIN®REDITABS®active ingredient

    10 ORALLY DISINTEGRATING TABLETS

    *When taken as directed. See Drug Facts Panel.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    5095193/R812

    This is the 10 count blister carton label for TopCare Loratadine ODT, USP 10 mg (Children's).
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  • INGREDIENTS AND APPEARANCE
    LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-528
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    Color white (white to off white) Score no score
    Shape ROUND (flat faced beveled edge) Size 10mm
    Flavor STRAWBERRY, TUTTI FRUTTI, MINT Imprint Code RC17
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-528-69 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077153 08/31/2007
    Labeler - Topco Associates LLC (006935977)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 manufacture(36800-528)
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