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

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WAL FEX ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]
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NDC 0363-0571-13, 0363-0571-22, 0363-0571-33, 0363-0571-39, 0363-0571-75, 0363-0571-95
Set ID ccb82db5-3936-4db0-b5b8-ae3b8ac2c59a
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA076447
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  • Active ingredient (in each tablet)

    Fexofenadine HCl 180 mg

  • Purpose

    Antihistamine

  • 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
  • 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)

  • 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
  • Other information

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

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    NON-DROWSY – ORIGINAL PRESCRIPTION STRENGTH

    Wal-Fex®

    Allergy

    Fexofenadine Hydrochloride Tablets, 180 mg / Antihistamine

    Relief of:

    Sneezing

    Runny nose

    Itchy, watery eyes

    Itchy nose or throat

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    180 mg EACH

    Actual Size

    Compare to Allegra® Allergy active ingredient

    Wal-Fex Carton Image 1
    Wal-Fex Carton Image 2
  • INGREDIENTS AND APPEARANCE
    WAL FEX ALLERGY 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0571
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorORANGE (peach) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 93;7253
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0571-131 in 1 CARTON06/03/2011
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0571-223 in 1 CARTON08/27/2011
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0571-331 in 1 CARTON09/09/2011
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0571-951 in 1 CARTON06/09/2011
    445 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0363-0571-391 in 1 CARTON04/14/2011
    530 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0363-0571-751 in 1 CARTON01/05/2012
    690 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07644704/14/2011
    Labeler - Walgreen Company (008965063)
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