Label: 24HR ALLERGY RELIEF- fexofenadine hydrochloride tablet

  • NDC Code(s): 70000-0726-1
  • Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 12, 2025

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  • Drug Facts Active ingredient (in each tablet)

    Fexofenadine Hydrochloride USP, 180 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory 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 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 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 carton is opened or if printed foil inner seal on the bottle is torn or missing.
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80,
    pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

  • Questions or comments?

    call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    180 LABEL

    180 CARTON

  • INGREDIENTS AND APPEARANCE
    24HR ALLERGY RELIEF 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0726
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code J;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0726-11 in 1 CARTON05/09/2025
    1180 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409708/19/2016
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
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