Home > Drugs A-Z > Fexofenadine hydrochloride

Fexofenadine hydrochloride (Physicians Total Care, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 30 TABLET in 1 BOTTLE (54868-6289-0) Label Information
TABLET 90 TABLET in 1 BOTTLE (54868-6289-1) 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 otherupper respiratory allergies:

    • runny nose
    • itchy, watery eys
    • sneezing
    • itching of the nose or Throad




  • 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 doctorshould 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

    Allergy

    an allergic reaction to this product occurs. Seek medical help right away.

    Pregnancy/Breastfeeding

    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 individual blister units are torn or opened.


  • Storage

    store between 20° - 25°C (68° - 77°F)

    protect from excessive moisture


  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.


  • Questions

    call toll-free 1-888-375-3784

    Manufactured by:

    Dr. Reddy’s Laboratories Louisiana LLC,

    8800 Line Ave Shreveport, LA, 71106. 

    OR

    Manufactured by:

    Dr. Reddy’s Laboratories Limited

    Bachepalli - 502 325 INDIA

    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, OK      74146


  • Principal Display Panel

    Fexofenadine HCl USP, 180 mg

    NDC 54868-6289-0

    image of package label


  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6289(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)  
    FERRIC OXIDE BLACK (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:54868-6289-0 30 in 1 BOTTLE
    2 NDC:54868-6289-1 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076502 07/27/2011
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel, repack