Label: ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, film coated

  • NDC Code(s): 41167-4120-0, 41167-4120-1, 41167-4120-2, 41167-4120-3, view more
    41167-4120-4, 41167-4120-5, 41167-4120-6, 41167-4121-0, 41167-4121-1, 41167-4121-2, 41167-4121-3, 41167-4121-4, 41167-4121-5, 41167-4121-6, 41167-4121-7, 41167-4124-0, 41167-4124-3, 41167-4124-5, 41167-4124-7, 41167-4124-8, 41167-4131-2, 41167-4131-4, 41167-4131-6
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 2, 2024

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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


  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4131-4
    Allegra
    ALLERGY
    60 mg/ antihistamine
    12 HR
    24 TABLETS

    NDC 41167-4131-4 Allegra ALLERGY 60 mg/ antihistamine 12 HR 24 TABLETS

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-4120-3
    Allegra
    ALLERGY
    180 mg/ antihistamine
    24 HR
    30 TABLETS

    NDC 41167-4120-3 Allegra ALLERGY 180 mg/ antihistamine 24 HR 30 TABLETS

  • PRINCIPAL DISPLAY PANEL

    Allegra
    ALLERGY
    180 mg/ antihistamine
    24 HR
    40 TABLETS

    Allegra ALLERGY 180 mg/ antihistamine 24 HR 40 TABLETS

  • PRINCIPAL DISPLAY PANEL

    Allegra
    ALLERGY
    180 mg/ antihistamine
    24 HR
    90 TABLETS

    Allegra ALLERGY 180 mg/ antihistamine 24 HR 90 TABLETS

  • INGREDIENTS AND APPEARANCE
    ALLEGRA ALLERGY 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (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:41167-4131-21 in 1 CARTON03/03/2011
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-4131-42 in 1 CARTON03/03/2011
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-4131-63 in 1 CARTON03/02/2019
    312 in 1 BLISTER PACK; 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: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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (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:41167-4120-11 in 1 CARTON03/03/2011
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-4120-01 in 1 CARTON03/03/2011
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-4120-23 in 1 CARTON03/03/2011
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:41167-4120-31 in 1 CARTON03/03/2011
    430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:41167-4120-41 in 1 CARTON03/03/2011
    545 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:41167-4120-52 in 1 CARTON03/03/201107/01/2022
    645 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:41167-4120-61 in 1 CARTON03/03/2011
    770 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: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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (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:41167-4121-22 in 1 POUCH03/03/201102/18/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-4121-32 in 1 PACKAGE03/03/201111/03/2018
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-4121-61 in 1 CARTON03/03/201104/04/2017
    337 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:41167-4121-71 in 1 CARTON03/03/201103/03/2017
    454 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:41167-4121-41 in 1 CARTON03/03/2011
    540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:41167-4121-52 in 1 CARTON03/03/201102/01/2018
    630 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:41167-4121-01 in 1 PACKAGE03/03/201102/18/2020
    71 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:41167-4121-11 in 1 CARTON06/01/2021
    860 in 1 BOTTLE; 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:41167-4124
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 018;E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4124-71 in 1 CARTON02/01/202104/30/2023
    184 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-4124-01 in 1 CARTON12/01/2020
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-4124-32 in 1 PACKAGE10/01/2020
    3NDC:41167-4124-555 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-4124-81 in 1 CARTON05/01/2022
    4100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02087210/01/2020
    Labeler - Chattem, Inc. (003336013)
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