Label: SMART SENSE ALLERGY RELIEF NON DROWSY- loratadine tablet

  • NDC Code(s): 49738-612-39, 49738-612-46, 49738-612-49, 49738-612-58, view more
    49738-612-72, 49738-612-75
  • Packager: Kmart Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 9, 2015

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

  • Active ingredient (in each tablet)

    Loratadine 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

    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

    do not use if blister unit is broken or torn (Blister configuration)
    do not use if printed foil under cap is broken or missing (Bottle configuration)
    store between 20° to 25°C (68° to 77°F)
    protect from excessive moisture
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  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN CLARITIN® TABLETS

    ACTUAL SIZE

    original prescription strength

    non-drowsy*

    allergy relief

    LORATADINE TABLETS, 10 mg / ANTIHISTAMINE

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    RELIEF OF:

    SNEEZING – RUNNY NOSE

    ITCHY, WATERY EYES – ITCHY THROAT OR NOSE

    30 TABLETS

    *When taken as directed. See Drug Facts Panel.

    Smart Sense Allergy Relief Image 1
    Smart Sense Allergy Relief Image 2
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  • INGREDIENTS AND APPEARANCE
    SMART SENSE ALLERGY RELIEF  NON DROWSY
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49738-612
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 8mm
    Flavor Imprint Code L612
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49738-612-46 10 in 1 CARTON
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:49738-612-39 30 in 1 CARTON
    2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:49738-612-72 1 in 1 CARTON
    3 60 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:49738-612-75 1 in 1 CARTON
    4 90 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:49738-612-49 40 in 1 CARTON
    5 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:49738-612-58 1 in 1 CARTON
    6 40 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076301 11/24/2010
    Labeler - Kmart Corporation (008965873)
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