Label: FEXOFENADINE HYDROCHLORIDE tablet

  • NDC Code(s): 62207-765-49, 62207-765-51, 62207-765-60, 62207-765-88, view more
    62207-766-35, 62207-766-49, 62207-766-51, 62207-766-58
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 31, 2023

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  • ACTIVE INGREDIENT(S)

    Fexofenadine HCl USP 60 mg (for 60 mg)

    Fexofenadine HCl USP 180 mg (for 180 mg)

  • PURPOSE

    Antihistamine

  • USE(S)

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


    • runny nose
    • itchy, water eyes
    • sneezing
    • 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.

  • DIRECTIONS

    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 (for 60 mg)
    take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
     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 foil printed with granules logo under bottle cap is opened or torn.
    • Do not use if carton is opened or if individual blister units are torn or opened.
    • store between 20º and 25ºC (68º and 77ºF)
    • protect from excessive moisture
  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

  • QUESTIONS OR COMMENTS

    Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

    Manufactured By:
    Granules India Limited    
    Hyderabad-500 081, India
    MADE IN INDIA

    Distributed By:
    Granules USA, Inc.
    Parsippany, NJ 07054

  • PRINCIPAL DISPLAY PANEL

    fexodenadine-label1-jpgfexofenadine-60mg-10s-carton



    fexofenadine-180mg-10s-carton.jpg

    Fexofenadine-USP-60mg-Label

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-765
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (PEACH) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code G5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-765-511 in 1 CARTON12/18/2020
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-765-491000 in 1 BOTTLE; Type 0: Not a Combination Product12/18/2020
    3NDC:62207-765-608 in 1 CARTON12/18/2020
    39 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62207-765-885 in 1 BOX11/17/2021
    410000 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107512/18/2020
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-766
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (PEACH) Scoreno score
    ShapeOVAL (Capsule-shaped) Size17mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-766-511 in 1 CARTON12/18/2020
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-766-491000 in 1 BOTTLE; Type 0: Not a Combination Product12/18/2020
    3NDC:62207-766-587 in 1 CARTON12/18/2020
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62207-766-3525000 in 1 BOX; Type 0: Not a Combination Product12/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107512/18/2020
    Labeler - Granules India Ltd (915000087)
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