Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated September 10, 2019

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  • Active ingredient(in each tablet)


    Fexofenadine HCl USP, 180 mg

    Fexofenadine HCl USP, 60 mg


  • Purpose


    Antihistamine

  • Uses


    temporarily relieves these symptoms due to hay fever or other upper resporatory 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 aluminium or magnesium antacids
    • do not take with fruit juices (see directions)
  • Stop use and ask 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




    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

    adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours;
    do not take more than 2 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 printed foil inner seal on bottle is torn or missing
    • store between 20°and 25°C (68°and 77°F)
    • protect from excessive moisture and light
  • Inactive ingredients



    anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

  • Questions or comments?


     call 1-855-274-4122

  • Principal Display Panel



    NDC 58602-711-19

    *Compare to 24 Hour Allegra®
    Allergy active ingrediant

    Original Prescription Strength Non-Drowsy

    Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
     
    Allergy
    Indoor & Outdoor Allergies

    24 Hours Relief of: 

     Sneezing 
     R    unny nose
    Itchy, Watery Eyes
    Itchy Nose or Throat


    DO NOT USE IF FOIL SEAL IS TORN OR MISSING

    90 Tablets 180 mg each


    Principal Display panel-180 mg-90s count
  • Principal Display Panel




    NDC 58602-710-40

    *Compare to 12 Hour Allegra®
    Allergy active ingredient

    Original Prescription Strength Non-Drowsy

    Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
     
    Allergy 
    Indoor & Outdoor Allergies

    12 Hours Relief of: 

     Sneezing 
     R    unny nose
    Itchy, Watery Eyes
    Itchy Nose or Throat


    DO NOT USE IF FOIL SEAL IS TORN OR MISSING 

    500 Tablets 60 mg each



    fexofenadinehcl
  • Principal Display Panel

    NDC 58602-710-40

    *Compare to 12 Hour Allegra®
    Allergy active ingredient

    Original Prescription Strength Non-Drowsy

    Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
     
    Allergy 
    Indoor & Outdoor Allergies

    12 Hours Relief of: 

     Sneezing 
     R    unny nose
    Itchy, Watery Eyes
    Itchy Nose or Throat


    DO NOT USE IF FOIL SEAL IS TORN OR MISSING 

    12 Tablets 60 mg each

    fexo-fig3

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-711
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (Peach) Scoreno score
    ShapeCAPSULE (Bevel Edge, Biconvex) Size17mm
    FlavorImprint Code E;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-711-191 in 1 CARTON01/15/2015
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-711-211 in 1 CARTON01/15/2015
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20203901/15/2015
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-710
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (peach) Scoreno score
    ShapeCAPSULE (Bevel Edge,Bioconvex) Size12mm
    FlavorImprint Code E;42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-710-401 in 1 CARTON; Type 0: Not a Combination Product10/05/2016
    2NDC:58602-710-751 in 1 CARTON; Type 0: Not a Combination Product10/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20203910/05/2016
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolife Pharma, LLC829084461MANUFACTURE(58602-710, 58602-711)
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