Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet, film coated

  • NDC Code(s): 0904-6979-40, 0904-6979-60
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 13, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Fexofenadine HCl 60 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
  • 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 (1-800-222-1222).

  • 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

    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

    do not use if carton is opened or printed foil under cap is broken or missing
    store between 20°-25°C (68°-77°F)
    protect from excessive moisture
    this product meets the requirements of USP Dissolution Test 3
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

  • Questions or comments?

    1-800-616-2471

  • Package/Label Principal Display Panel

    Compare to the active ingredient in Allegra® Allergy

    NON-DROWSY

    Fexofenadine Hydrochloride Tablets

    60 mg

    Antihistamine

    12 HR

    INDOOR/OUTDOOR ALLERGY RELIEF

    -Sneezing

    -Runny Nose

    -Itchy, Watery Eyes

    Itchy Nose or Throat

    Allergy

    Actual Size

    100 Tablets

    425-5c-fexofenadine-hydrochloride-tablets
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6979
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (Peach) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 93;7252
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6979-40500 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2011
    2NDC:0904-6979-601 in 1 CARTON10/17/2019
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07644708/08/2011
    Labeler - Major Pharmaceuticals (191427277)