Label: FEXOFENADINE HCL tablet

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

Drug Label Information

Updated December 26, 2023

If you are a consumer or patient 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

    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 take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours


  • Other information

    ■ safety sealed: do not use if imprinted safety seal under cap is broken or missing
    ■ store between 20° and 25°C (68° and 77°F)
    ■ protect from excessive moisture

  • Inactive ingredients

    ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,
    pregelatinized starch, propylene glycol, shellac, titanium dioxide.

  • Questions or comments?

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

  • PDP

    Fexo 180mg Gelcaps

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-768
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    AMMONIA (UNII: 5138Q19F1X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorgray ((White band in the middle)) Scoreno score
    ShapeOVAL ((capsule shaped tablet)) Size20mm
    FlavorImprint Code G18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-768-0660 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107501/01/2024
    Labeler - CVS (062312574)