Label: FEXOFENADINE HCL tablet, film coated

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

Drug Label Information

Updated January 16, 2024

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  • ALLERGY Active ingredient (in each film-coated tablet)

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

  • Directions

    adults and children 12 years of age and over

    take one 60mg 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

    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • each tablet contains: sodium 2.7mg(for 60 mg)
    • this product meets the requirements of USP Dissolution Test 2
  • Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

  • Questions or comments?

    Call toll-free  1-800-616-2471

  • HOW SUPPLIED

    NDC: 71335-2165-1: 30 Tablets in a BOTTLE

    NDC: 71335-2165-2: 10 Tablets in a BOTTLE

    NDC: 71335-2165-3: 60 Tablets in a BOTTLE

    NDC: 71335-2165-4: 90 Tablets in a BOTTLE

    NDC: 71335-2165-5: 14 Tablets in a BOTTLE

    NDC: 71335-2165-6: 20 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Fexofenadine Hcl 60mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-2165(NDC:0904-7192)
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SG;201
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-2165-130 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
    2NDC:71335-2165-210 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
    3NDC:71335-2165-360 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
    4NDC:71335-2165-490 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
    5NDC:71335-2165-514 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
    6NDC:71335-2165-620 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450708/26/2021
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-2165) , RELABEL(71335-2165)
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