Label: FEXOFENADINE tablet, film coated

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

Drug Label Information

Updated March 5, 2012

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  • Active ingredient (in each tablet)

    For 30 mg:

    Fexofenadine HCl 30 mg

    For 60 mg:

    Fexofenadine HCl 60 mg

    For 180 mg:

    Fexofenadine HCl 180 mg

  • Purpose

    Antihistamine

  • Uses

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings

    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

    • trouble swallowing                    
    • dizziness or loss of consciousness
    • swelling of tongue
    • swelling in or around mouth
    • trouble speaking
    • drooling
    • wheezing or problems breathing

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

    Do not use

    ●   to prevent hives from any known cause such as:

    • foods
    • insect stings
    • medicines
    • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

    ●   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.
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch

    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.
    • symptoms do not improve after 3 days of treatment
    • the hives have lasted more than 6 weeks

    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.

  • Directions

    For 30 mg:

    adults and children 12 years of age and over
    		take two 30 mg tablets with water every 12 hours;
    do not take more than 4 tablets in 24 hours
    children 6 to under 12 years of age
    		take one 30 mg tablet with water every 12 hours;
    do not take more than 2 tablets in 24 hours
    children under 6 years of age
    		do not use
    adults 65 years of age and older
    		ask a doctor
    consumers with kidney disease
    		ask a doctor

    For 60 mg:

    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

    For 180 mg:

    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

    • safety sealed: do not use if carton is open or if individual blister unit is torn or open
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

  • Questions or comments?

    Call toll-free 1-800-346-6854

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Blister
    Carton
    Blister
    Carton
    Blister
    Carton
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE 
    fexofenadine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (round) Size7mm
    FlavorImprint Code W;30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-744-071 in 1 CARTON
    1NDC:64679-744-066 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07911202/08/2012
    FEXOFENADINE 
    fexofenadine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-982
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULE (Capsule) Size11mm
    FlavorImprint Code W;982
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-982-072 in 1 CARTON
    1NDC:64679-982-066 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07911202/08/2012
    FEXOFENADINE 
    fexofenadine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-987
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULE (Capsule) Size17mm
    FlavorImprint Code W;987
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-987-081 in 1 CARTON
    1NDC:64679-987-075 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07911202/08/2012
    Labeler - Wockhardt USA LLC. (170508365)
    Registrant - Wockhardt USA LLC. (170508365)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wockhardt Limited676257570Manufacture
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