Label: FEXOFENADINE HCL tablet

  • NDC Code(s): 70010-183-03
  • Packager: GRANULES PHARMACEUTICALS INC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 25, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each tablet)

    Fexofenadine HCl USP, 180 mg

  • Purpose

    Antihistamine

  • Uses

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


    ■runny nose

    ■ itchy, watery eyes

    ■ sneezing

    ■ itching of the nose or throat

  • 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

    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 180mg 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 imprinted foil under bottle cap is opened or torn.
    ■store between 20° and 25°C (68° and 77°F)
    ■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?

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

  • Principal Display Panel

    30ct carton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70010-183
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (peach) Scoreno score
    ShapeOVALSize17mm
    FlavorImprint Code G6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70010-183-0330 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107504/25/2023
    Labeler - GRANULES PHARMACEUTICALS INC. (079825711)