FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]

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  • FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]

FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PERRIGO NEW YORK INC]
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NDC 45802-571-78, 45802-571-87
Set ID cce5b39f-dd3f-4621-8a18-454756c4eb7e
Category HUMAN OTC DRUG LABEL
Packager Perrigo New York Inc
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 carton is opened or printed foil under cap is broken or missing
    •
    store between 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

    Compare to Allegra® Allergy active ingredient

    Fexofenadine Hydrochloride Tablets, 180 mg

    Antihistamine

    24 HR INDOOR/OUTDOOR ALLERGY RELIEF

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Nose or Throat

    NON-DROWSY

    actual size

    100 TABLETS

    Allergy

    571-rt-fexofenadine-hydrochloride.jpg
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-571
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (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:45802-571-781 in 1 CARTON04/22/2011
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:45802-571-871 in 1 CARTON04/22/201104/22/2011
    2300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07644704/22/2011
    Labeler - Perrigo New York Inc (078846912)
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