Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated August 26, 2015

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  • Active ingredient (in each tablet)


    For 60 mg:

    Fexofenadine HCl USP, 60 mg


    For 180 mg:

    Fexofenadine HCl USP, 180 mg

  • 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 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

    For 60 mg:

    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

    For 180 mg:

    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 age do not use
     adults 65 years of age and older ask a doctor
     consumers with kidney disease ask 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, stearic acid, titanium dioxide, and yellow iron oxide

  • Questions or comments?


    call toll free 1-866-850-2876 



  • Principal Display Panel - 60 mg 500's count



    NDC 13107-066-05


    *Compare to 12 Hour Allegra®
    Allergy active ingredient

    Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
     
    Allergy 

    Relief of: 

     Sneezing
     R    unny nose
    Itchy, watery eyes
    Itchy nose or throat           12 Hour

    Indoor & Outdoor Allergies

    DO NOT USE IF FOIL SEAL IS TORN OR MISSING

    500 Tablets 60 mg each



    fexofenadine60mg

  • Principal Display Panel - 180 mg 500's count

    NDC 13107-067-05


    *Compare to 24 Hour Allegra®
    Allergy active ingredient

    Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine

    Allergy

    Relief of:

    Sneezing
    R    unny nose
    Itchy, watery eyes
    Itchy nose or throat   24 Hour

    Indoor & Outdoor Allergies

    DO NOT USE IF FOIL SEAL IS TORN OR MISSING

    500 Tablets 180 mg each


    Fexo180mg
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13107-066
    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)  
    COLLOIDAL 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) Size12mm
    FlavorImprint Code E;42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13107-066-051 in 1 CARTON
    1500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20203908/26/2015
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13107-067
    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)  
    COLLOIDAL 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:13107-067-051 in 1 CARTON
    1500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20203911/19/2014
    Labeler - Aurolife Pharma, LLC (829084461)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolife Pharma, LLC829084461MANUFACTURE(13107-066, 13107-067)
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