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Fexofenadine hydrochloride (Dr. Reddy's Laboratories Limited)

Available Formats

Dosage Form Package Information Links
TABLET 1 BLISTER PACK in 1 CARTON (55111-784-07) > 5 TABLET in 1 BLISTER PACK Label Information
TABLET 2 BOTTLE in 1 CARTON (55111-784-43) > 30 TABLET in 1 BOTTLE (55111-784-30) Label Information
TABLET 30 TABLET in 1 BOTTLE (55111-784-30) Label Information
TABLET 3 BLISTER PACK in 1 CARTON (55111-784-29) > 5 TABLET in 1 BLISTER PACK Label Information
TABLET 90 TABLET in 1 BOTTLE (55111-784-90) Label Information
TABLET 45 TABLET in 1 BOTTLE (55111-784-45) Label Information

Complete Fexofenadine hydrochloride Information

  • Active ingredient(s)

    Fexofenadine HCl USP, 180 mg


  • Purpose

    Antihistamine


  • Use(s)

    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 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 180 mg 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 bottle is torn or missing


  • Storage

    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 2


  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide


  • Questions?

    Call 1-888-375-3784


  • Carton label

    carton


  • Bottle label

    label


  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-784
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) Fexofenadine Hydrochloride 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color PINK Score no score
    Shape OVAL Size 7mm
    Flavor Imprint Code 194;R
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-784-30 1 in 1 CARTON 01/03/2011
    1 30 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:55111-784-43 2 in 1 CARTON 01/03/2011
    2 30 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:55111-784-40 1 in 1 CARTON 01/03/2011
    3 40 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:55111-784-45 1 in 1 CARTON 01/03/2011
    4 45 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:55111-784-59 2 in 1 CARTON 01/03/2011
    5 60 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:55111-784-75 1 in 1 CARTON 01/03/2011
    6 70 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:55111-784-90 1 in 1 CARTON 01/03/2011
    7 90 in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:55111-784-01 1 in 1 CARTON 01/03/2011
    8 100 in 1 BOTTLE; Type 0: Not a Combination Product
    9 NDC:55111-784-15 1 in 1 CARTON 01/03/2011
    9 150 in 1 BOTTLE; Type 0: Not a Combination Product
    10 NDC:55111-784-18 1 in 1 CARTON 01/03/2011
    10 180 in 1 BOTTLE; Type 0: Not a Combination Product
    11 NDC:55111-784-05 1 in 1 CARTON 01/03/2011
    11 500 in 1 BOTTLE; Type 0: Not a Combination Product
    12 NDC:55111-784-23 1 in 1 CARTON 01/03/2011
    12 2 in 1 BLISTER PACK; Type 0: Not a Combination Product
    13 NDC:55111-784-07 1 in 1 CARTON 01/03/2011
    13 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    14 NDC:55111-784-29 3 in 1 CARTON 01/03/2011
    14 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    15 NDC:55111-784-78 10 in 1 CARTON 01/03/2011
    15 NDC:55111-784-79 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    16 NDC:55111-784-28 3 in 1 CARTON 01/03/2011
    16 15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076502 01/03/2011
    Labeler - Dr. Reddy's Laboratories Limited (650562841)
    Establishment
    Name Address ID/FEI Business Operations
    Dr. Reddy's Laboratories Limited (FTO III) 918608162 analysis(55111-784) , manufacture(55111-784)
    Establishment
    Name Address ID/FEI Business Operations
    Reed-Lane, Inc. 001819879 repack(55111-784)