Label: FEXOFENADINE HCL tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 7, 2024

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  • Active Ingredient (in each tablet)

    Fexofenadine HCl USP, 180mg

  • 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

  • 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 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 ask a doctor
    and older

    consumers with kidney ask a doctor
    disease

  • 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?

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

  • Principal Display Panel

    Fexo 180mg Gelcaps

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-6230
    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
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    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:79481-6230-660 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107507/01/2024
    Labeler - Meijer, Inc. (006959555)
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