Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 0363-0095-24, 0363-0097-53, 0363-0097-55
  • Packager: Walgreen CO
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 10, 2019

If you are a consumer or patient please visit this version.

  • 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 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


    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

    • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or opened
    • 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- 60 mg 24 ct

    NDC 0363-0095-24
    NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
    Wal-Fex
    12 HOUR ALLERGY
    Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
    12 Hour, TABLETS
    INDOOR & OUTDOOR ALLERGIES
    Relief of  Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
    24 Tablets 60 mg each
    walfex-fig1

  • Principal Display Panel- 180 mg 15 ct


    NDC 0363-0097-53
    NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
    Wal-Fex
    Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
    24 Hour, TABLETS
    INDOOR & OUTDOOR ALLERGIES
    Relief of  Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
    15 Tablets 180 mg each
    Walfex-fig2




  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0097
    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:0363-0097-551 in 1 CARTON01/15/2015
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0097-531 in 1 CARTON01/15/2015
    215 in 1 BLISTER PACK; 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:0363-0095
    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:0363-0095-241 in 1 CARTON10/05/2016
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20203910/05/2016
    Labeler - Walgreen CO (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolife Pharma, LLC829084461MANUFACTURE(0363-0095, 0363-0097)