Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated

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

Drug Label Information

Updated December 19, 2016

If you are a consumer or patient please visit this version.

  •  

    Non-Drowsy

    Indoor/Outdoor Allergy Relief

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

    Close
  • Active ingredient (in each tablet)

    Fexofenadine hydrochloride USP

    Close
  • Purpose

    Antihistamine

    Close
  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat
    Close
  • Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

    Close
  • Ask a doctor before use

    if you have kidney disease. Your doctor should determine if you need a different dose.

    Close
  • 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)
    Close
  • Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

    Close
  • If pregnant or breast-feeding,

    ask a health professional before use.

    Close
  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Close
  • Directions - 60 mg (12 Hour Relief)

    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

    Directions - 180 mg (24 Hour Relief)

    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

    Close
  • Other information

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
    protect from excessive moisture
    Close
  • Inactive ingredients

    Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

    Close
  • Questions?

    1-800-848-0462

    Serious side effects associated with use of this product may be reported to this number.
    Close
  • HOW SUPPLIED

    Fexofenadine Hydrochloride Tablets, USP are available containing 60 mg or 180 mg of fexofenadine hydrochloride, USP.

    The 60 mg tablets are blue film-coated, round, biconvex, beveled edge, unscored tablets debossed with M over 753 on one side of the tablet and blank on the other side. They are available as follows:

    NDC 51079-547-20 - Unit dose blister packages of 100
    (10 cards of 10 tablets each).

    The 180 mg tablets are blue film-coated, caplet-shaped, biconvex, beveled edge, unscored tablets debossed with M 755 on one side of the tablet and blank on the other side. They are available as follows:

    NDC 51079-548-20 - Unit dose blister packages of 100
    (10 cards of 10 tablets each).

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

    Protect from excessive moisture.

    Manufactured by:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    S-11117 R4
    12/16

    Close
  • Principal Display Panel – 60 mg

    NDC 51079-547-20

    Fexofenadine HCl
    Tablets, USP
    60 mg

    Antihistamine

    Non-Drowsy

    Indoor/Outdoor Allergy Relief

    12 HR

    (See Uses section of enclosed leaflet)

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
    TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

    Manufactured by:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    S-11114 R4

    This unit dose package is not child resistant.
    For institutional use only.
    Keep this and all drugs out of the reach of children.
    This container provides light-resistance.
    See window for lot number and expiration date.

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    Fexofenadine Hydrochloride Tablets, USP 60 mg Carton Label
    Outer Carton Label
    Close
  • Principal Display Panel – 180 mg

    NDC 51079-548-20

    Fexofenadine HCl
    Tablets, USP
    180 mg

    Antihistamine

    Non-Drowsy

    Indoor/Outdoor Allergy Relief

    24 HR

    (See Uses section of enclosed leaflet)

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
    TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

    Manufactured by:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    S-11115 R3

    This unit dose package is not child resistant.
    For institutional use only.
    Keep this and all drugs out of the reach of children.
    This container provides light-resistance.
    See window for lot number and expiration date.

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    Fexofenadine Hydrochloride Tablets, USP 120 mg Carton Label
    Outer Carton Label
    Close
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51079-547(NDC:0378-0781)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code M;753
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51079-547-20 100 in 1 BOX, UNIT-DOSE 02/13/2012
    1 NDC:51079-547-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077081 02/13/2012
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51079-548(NDC:0378-0782)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL (capsule-shaped) Size 18mm
    Flavor Imprint Code M;755
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51079-548-20 100 in 1 BOX, UNIT-DOSE 09/27/2011
    1 NDC:51079-548-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077081 09/27/2011
    Labeler - Mylan Institutional Inc. (039615992)
    Close