Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 3, 2012

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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 (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
  • 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


    NDC 66336-0561-XX

    NDC 66336-0561-XX
    NDC 66336-0561-30


    COMPARE TO active ingredient of  ALLEGRA® ALLERGY TABLETS

    Original Prescription Strength

    FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

    Antihistamine
    ALLERGY

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Nose or Throat

    Indoor and Outdoor Allergies

    24 HOUR

    Non-Drowsy

    actual size

    180 mg EACH
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66336-561(NDC:0904-6214)
    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 GLYCOLS (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:66336-561-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07644704/14/2011
    Labeler - Dispensing Solutions, Inc. (066070785)
    Registrant - PSS World Medical, Inc. (101822682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785relabel, repack
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