Label: ALLERGY RELIEF MEDICATION- loratadine tablet

  • NDC Code(s): 11673-315-10, 11673-315-15, 11673-315-18, 11673-315-30, view more
    11673-315-40, 11673-315-60
  • Packager: Target Brands, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/10

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

  • Active ingredient

    loratadine 10mg

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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
  • Adverse Reactions
  • Do Not Use

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

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  • Ask Doctor

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

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  • When Using

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

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  • Stop Use

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

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  • Pregnancy or Breast Feeding

    If pregnant or breast-feeding, ask a health professional before use.

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  • Keep Out of Reach of Children

    Keep out of reach of children.

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  • Overdose

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Other Information

    • safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only)
    • safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only)
    • store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)
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  • 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
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  • Inactive ingredients

    lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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  • Questions

    call 1-800-452-0051

     

     Distributed by Target Corp.

    Minneapolis, MN 55403

    copyright 2009 Target Brands, Inc.

    All Rights Persevered

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  • Principal Display

    Target Allergy Relief

    Target

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF MEDICATION 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11673-315
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (LORATADINE) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code GG;296
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-315-10 2 in 1 CARTON
    1 5 in 1 BLISTER PACK
    2 NDC:11673-315-40 4 in 1 CARTON
    2 10 in 1 BLISTER PACK
    3 NDC:11673-315-18 1 in 1 CARTON
    3 180 in 1 BOTTLE
    4 NDC:11673-315-60 6 in 1 CARTON
    4 10 in 1 BLISTER PACK
    5 NDC:11673-315-30 3 in 1 CARTON
    5 10 in 1 BLISTER PACK
    6 NDC:11673-315-15 3 in 1 CARTON
    6 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075209 01/31/2010
    Labeler - Target Brands, Inc. (006961700)
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