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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC:63824-926
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fexofenadine Hydrochloride (Fexofenadine) Fexofenadine Hydrochloride 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    silicon dioxide  
    starch, corn  
    croscarmellose sodium  
    FD&C Red no. 40  
    hypromelloses  
    ferrosoferric oxide  
    magnesium stearate  
    mannitol  
    polyethylene glycols  
    powdered cellulose  
    titanium dioxide  
    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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