WAL FEX 24 HOUR ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]

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WAL FEX 24 HOUR ALLERGY (FEXOFENADINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]
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NDC 0363-0600-01, 0363-0600-13, 0363-0600-22, 0363-0600-33, 0363-0600-39, 0363-0600-47, 0363-0600-49, 0363-0600-75, 0363-0600-95
Set ID bb7480e4-4693-4adc-ba74-3c8acf0488d4
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 (Blister only)
    •
    do not use if printed foil under cap is broken or missing (Bottle/Carton 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

    BONUS SIZE | BUY 30 & GET 10 FREE

    NON-DROWSY - ORIGINAL PRESCRIPTION STRENGTH

    Wal-Fex® 24 Hour Allergy

    Fexofenadine Hydrochloride Tablets 180 mg / Antihistamine

    Relief of sneezing, runny nose, itchy, watery eyes & itchy nose or throat

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    40 TABLETS 180 mg each (30 + 10 FREE)

    Actual Size

    Compare to Allegra® Allergy active ingredient

    Well at Walgreens Wal-Fex image 1
    Well at Walgreens Wal-Fex image 2
  • INGREDIENTS AND APPEARANCE
    WAL FEX 24 HOUR ALLERGY 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0600
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (peach) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 93;7253
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0600-135 in 1 CARTON03/06/2014
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0600-2215 in 1 CARTON03/06/2014
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0600-391 in 1 CARTON03/06/2014
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0600-951 in 1 CARTON03/06/2014
    445 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0363-0600-011 in 1 CARTON03/06/2014
    570 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0363-0600-751 in 1 CARTON03/06/2014
    690 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0363-0600-471 in 1 CARTON03/06/2014
    7150 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0363-0600-331 in 1 CARTON03/06/2014
    860 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0363-0600-491 in 1 CARTON03/06/2014
    940 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07644703/06/2014
    Labeler - Walgreen Company (008965063)
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