Label: SMART SENSE ALLERGY RELIEF- fexofenadine hydrochloride tablet, film coated 

  • NDC Code(s): 49738-571-13, 49738-571-33, 49738-571-39, 49738-571-49, view more
    49738-571-95
  • Packager: Kmart Corporation
  • 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 03/14

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

  • Active ingredient (in each tablet)

    Fexofenadine HCl 180 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

    kidney disease. Your doctor should determine if you need a different dose.

    When using this product

    do not take more than directed
    do not take at the same time as aluminum or magnesium antacids
    do not take with fruit juices (see Directions)

    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 12 years of age and over

    take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

    children under 12 years of age

    do not use

    adults 65 years of age and older

    ask a doctor

    consumers with kidney disease

    ask a doctor

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  • Other information

    do not use if blister unit is broken or torn (Use for Blister Configurations Only)
    do not use if printed foil under cap is broken or missing (Use for Bottle Configurations Only)
    store at 20°-25°C (68°-77°F)
    protect from excessive moisture
    this product meets the requirements of USP Dissolution Test 3
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to the active ingredient of Allegra® Allergy Tablets

    Original Prescription Strength

    Non-Drowsy

    INDOOR & OUTDOOR ALLERGIES

    Allergy Relief

    Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine

    24 HOUR ™

    RELIEF OF:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Nose or Throat

    ACTUAL SIZE

    5 TABLETS

    180 mg EACH

    Smart Sense Allergy Relief Image 1
    Smart Sense Allergy Relief Image 2
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  • INGREDIENTS AND APPEARANCE
    SMART SENSE ALLERGY RELIEF 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49738-571
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE YELLOW  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    TITANIUM DIOXIDE  
    FERRIC OXIDE RED  
    Product Characteristics
    Color ORANGE (peach) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code 93;7253
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49738-571-39 1 in 1 CARTON
    1 30 in 1 BOTTLE
    2 NDC:49738-571-95 1 in 1 CARTON
    2 45 in 1 BOTTLE
    3 NDC:49738-571-13 5 in 1 CARTON
    3 1 in 1 BLISTER PACK
    4 NDC:49738-571-33 1 in 1 CARTON
    4 60 in 1 BOTTLE
    5 NDC:49738-571-49 1 in 1 CARTON
    5 40 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076447 06/23/2011
    Labeler - Kmart Corporation (008965873)
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