Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet, film coated

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

Drug Label Information

Updated December 27, 2021

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  • 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?

    1-800-719-9260

  • HOW SUPPLIED

    NDC: 71335-0290-1: 30 Tablets in a BOTTLE

    NDC: 71335-0290-2: 10 Tablets in a BOTTLE

    NDC: 71335-0290-3: 60 Tablets in a BOTTLE

    NDC: 71335-0290-4: 90 Tablets in a BOTTLE

    NDC: 71335-0290-5: 14 Tablets in a BOTTLE

    NDC: 71335-0290-6: 20 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Fexofenadine Hcl 60mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0290(NDC:45802-425)
    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:71335-0290-130 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2013
    2NDC:71335-0290-210 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2013
    3NDC:71335-0290-360 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2013
    4NDC:71335-0290-490 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2013
    5NDC:71335-0290-514 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2013
    6NDC:71335-0290-620 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07644708/08/2011
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0290) , RELABEL(71335-0290)
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