Label: 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.

  • Active ingredient (in each tablet)

    Fexofenadine hydrochloride USP

  • Purpose

    Antihistamine

  • 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
  • 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.

  • 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

  • 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
  • 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.

  • Questions?

    1-800-848-0462

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

  • 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
  • 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
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-547(NDC:0378-0781)
    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
    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
    ColorBLUEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code M;753
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51079-547-20100 in 1 BOX, UNIT-DOSE02/13/2012
    1NDC:51079-547-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07708102/13/2012
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-548(NDC:0378-0782)
    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
    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
    ColorBLUEScoreno score
    ShapeOVAL (capsule-shaped) Size18mm
    FlavorImprint Code M;755
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51079-548-20100 in 1 BOX, UNIT-DOSE09/27/2011
    1NDC:51079-548-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07708109/27/2011
    Labeler - Mylan Institutional Inc. (039615992)