WAL FEX (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]

WAL FEX (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]
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NDC 0363-0903-53, 0363-0903-62
Set ID 15ad58b4-4056-4602-a663-d600224ae92d
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA076447
  • Active ingredient (in each tablet)

    Fexofenadine HCl 60 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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
    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

    NON-DROWSY

    Wal-Fex®

    Compare to Allegra® Allergy active ingredient

    12 HOUR ALLERGY

    FEXOFENADINE HYDROCHLORIDE TABLETS 60 mg / ANTIHISTAMINE

    12 HOUR TABLETS

    Indoor/outdoor allergy relief of sneezing; runny nose; itchy, watery eyes & itchy nose or throat

    12 HOUR

    24 TABLETS

    ACTUAL SIZE

    425-94-wal-fex.jpg
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  • INGREDIENTS AND APPEARANCE
    WAL FEX 
    fexofenadine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0903
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color ORANGE (Peach) Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 93;7252
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0903-53 12 in 1 CARTON 08/22/2011
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0363-0903-62 24 in 1 CARTON 07/08/2016
    2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076447 08/22/2011
    Labeler - Walgreen Company (008965063)
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