Label: MUCINEX ALLERGY- fexofenadine hydrochloride tablet

  • NDC Code(s): 63824-926-05, 63824-926-10, 63824-926-30, 63824-926-40, view more
    63824-926-60, 63824-926-80, 63824-926-88
  • Packager: Reckitt Benckiser LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 04/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Fexofenadine HCl USP, 180 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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.

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  • 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
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  • Other information

    • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 2
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  • 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

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  • Questions?

    Call 1-855-419-9622

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  • SPL UNCLASSIFIED SECTION

    Dist. By Reckitt Benckiser
    Parsippany, NJ 07054-0224
    Made in India

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  • PRINCIPAL DISPLAY PANEL - 180 mg Blister Pack Carton

    NEW

    NDC 63824-926-10

    NON-DROWSY
    Mucinex®
    ALLERGY

    Fexofenadine Hydrochloride Tablets USP, 180 mg/Antihistamine

    INDOOR & OUTDOOR ALLERGY RELIEF

    24hr

    ORIGINAL
    PRESCRIPTION STRENGTH

    ✓ Sneezing
    ✓ Runny Nose
    ✓ Itchy, Watery Eyes
    ✓ Itchy Nose or Throat

    10 TABLETS 180 mg each

    Principal Display Panel - 180 mg Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    MUCINEX   ALLERGY
    fexofenadine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-926
    Route of Administration ORAL DEA Schedule     
    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)  
    starch, corn (UNII: O8232NY3SJ)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    hypromelloses (UNII: 3NXW29V3WO)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    powdered cellulose (UNII: SMD1X3XO9M)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    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:63824-926-05 1 in 1 CARTON
    1 5 in 1 BLISTER PACK
    2 NDC:63824-926-10 1 in 1 CARTON
    2 10 in 1 BLISTER PACK
    3 NDC:63824-926-30 3 in 1 CARTON
    3 10 in 1 BLISTER PACK
    4 NDC:63824-926-40 4 in 1 CARTON
    4 10 in 1 BLISTER PACK
    5 NDC:63824-926-80 2 in 1 CARTON
    5 NDC:63824-926-40 4 in 1 CARTON
    5 10 in 1 BLISTER PACK
    6 NDC:63824-926-60 6 in 1 CARTON
    6 10 in 1 BLISTER PACK
    7 NDC:63824-926-88 8 in 1 CARTON
    7 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076502 01/02/2014
    Labeler - Reckitt Benckiser LLC (094405024)
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