Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated January 20, 2020

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

  • Active ingredient

    (in each film-coated tablet)

    Fexofenadine HCl 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

  • 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 and 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

    ■ store between 20°and 25°C (68°and 77°F)

    ■ protect from excessive moisture

    each tablet contains: sodium 8.2 mg

    ■ this product meets the requirements of USP Dissolution Test 2

    Tamper Evident: Do not use if imprinted inner safety seal is torn or missing

  • Inactive ingredients

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

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

  • PRINCIPAL DISPLAY PANEL

    32 count

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-002
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeOVAL (Capsule shaped, biconvex film coated tablets) Size17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-002-3232 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450704/13/2018
    Labeler - Granules USA, Inc (137098864)