Label: LORATADINE- loratadine tablet, orally disintegrating

  • NDC Code(s): 11673-513-69, 11673-527-31
  • Packager: Target Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • 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, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

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  • QUESTIONS?

    Call 1-800-910-6874

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  • PRINCIPAL DISPLAY PANEL

    NDC 11673-513-12

    Original Prescription Strength

    non-drowsy**

    allergy relief

    loratadine orally disintegrating tablets, 10 mg

    antihistamine

    indoor & outdoor allergies

    Compare to active ingredient in Alavert®*

    24 HOUR RELIEF

    24-hour allergy relief of: sneezing/

    runny nose/itchy nose and throat

    no water needed/tablets melt in your mouth

    for adults and children 6 years and older

    mint flavor

    **When taken as directed.

    See drug facts panel.

    up & up

    12 ORALLY DISINTEGRATING TABLETS

    Distributed by Target Corporation

    5079395/R1210

    This is the 12 count blister carton label for Target Loratadine ODT (Alavert like).

    Alavert - 12's

    NDC 11673-527-31

    Original Prescription Strength

    non-drowsy**

    allergy relief

    loratadine orally disintegrating tablets,

    10 mg antihistamine

    indoor & outdoor allergies

    Compare to active ingredient in Claritin®Reditabs®*

    24-hour allergy relief of: sneezing/runny

    nose/itchy, watery eyes/itchy throat or nose

    no water needed/tablets melt in your mouth

    for adults and children 6 years and older

    **When taken as directed.

    See drug facts panel.

    up & up

    24 HOUR RELIEF

    30 ORALLY DISINTEGRATING TABLETS

    Distributed by Target Corp.

    5079394/R1210

    This is the 30 count blister carton label for Target Loratadine ODT (Claritin like).

    Claritin - 30's

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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-513
    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 FRUIT Imprint Code RC17
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-513-69 1 in 1 CARTON
    1 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
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-527
    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 FRUIT Imprint Code RC17
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-527-31 1 in 1 CARTON
    1 30 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 - Target Corporation (006961700)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture(11673-513)
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