Label: ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, film coated

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

Drug Label Information

Updated February 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Allegra Allergy

    Allegra Allergy® - 12/24 HOUR

    Drug Facts

  • Active ingredient

    (in each tablet)
    12 Hour Tablet: Fexofenadine HCl 60 mg

    24 Hour Tablet: Fexofenadine HCl 180 mg

  • Purpose

    Antihistamine

  • Uses

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

    • runny nose
    • sneezing
    • itchy, water 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.

  • Allegra 12 Hour Directions

     adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take
    more than 2 tablets in 24 hours
     children under 12 years of agedo not use
     adults 65 years of age and olderask a doctor
     consumers with kidney diseaseask a doctor
  • Allegra 24 Hour Directions

     adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take
    more than 1 tablet in 24 hours
     children under 12 years of agedo not use
     adults 65 years of age and olderask a doctor
     consumers with kidney diseaseask a doctor
  • Other information

    • safety sealed: do not use if carton is opened or if individual blister units are torn or opened or if inner foil seal on bottle is torn or missing
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

  • Questions or comments?

    call toll-free 1-800-633-1610 or www.allegra.com


  • HOW SUPPLIED

    Product: 50090-1234

    NDC: 50090-1234-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC / 1 in a CARTON

    Product: 50090-1235

    Product: 50090-1845

  • fexofenadine hydrochloride

    Label Image
  • fexofenadine hydrochloride

    Label Image
  • fexofenadine hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1234(NDC:41167-4120)
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Product Characteristics
    Colororange (peach) Scoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 018;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1234-01 in 1 CARTON11/28/2014
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087203/03/2011
    ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1235(NDC:41167-4131)
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Product Characteristics
    ColorORANGE (peach) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 06;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1235-01 in 1 CARTON11/28/201409/30/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087203/03/201109/30/2021
    ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1845(NDC:41167-4121)
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Product Characteristics
    Colororange (peach) Scoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 018;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1845-01 in 1 CARTON05/26/201504/30/2016
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087203/03/201104/30/2016
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-1234, 50090-1235, 50090-1845)
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