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Fexofenadine Hydrochloride (Dispensing Solutions, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 14 TABLET, FILM COATED in 1 BOTTLE (66336-560-14) Label Information
TABLET, FILM COATED 30 TABLET, FILM COATED in 1 BOTTLE (66336-560-30) Label Information

Complete Fexofenadine Hydrochloride Information

  • 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

  • Other information

    • do not use if printed foil under cap is broken or missing
    • store at 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

    1-800-719-9260


  • Package/Label Principal Display Panel

    NDC 66336-0560-XX

    NDC 66336-0560-XX
    NDC 66336-0560-14
    NDC 66336-0560-30


    Compare to Allegra® Allergy active ingredient

    Fexofenadine Hydrochloride Tablets, 60 mg

    Antihistamine

    Non-Drowsy

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Nose or Throat

    Original Prescription Strength

    12 Hour

    60 mg Each

    Actual Size

    Indoor and Outdoor Allergies

    Allergy



  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66336-560(NDC:45802-425)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color orange (Peach) Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 93;7252
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66336-560-14 14 in 1 BOTTLE
    2 NDC:66336-560-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076447 08/08/2011
    Labeler - Dispensing Solutions, Inc. (066070785)
    Registrant - PSS World Medical, Inc. (101822682)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 relabel, repack