Label: MUCINEX D - guaifenesin and pseudoephedrine hydrochloride tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 12/09

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release bi-layer tablet) Purpose
    Guaifenesin 600 mg Expectorant
    Pseudoephedrine HCl 60 mg Nasal Decongestant
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  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves nasal congestion due to:
      • common cold
      • hay fever
      • upper respiratory allergies
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • temporarily relieves sinus congestion and pressure
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  • Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

    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

    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regard for timing of meals
    • adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
    • children under 12 years of age: do not use
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  • Other information

    • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
    • store at 20-25°C (68-77°F)
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  • Inactive ingredients

    carbomer 934P, NF; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Reckitt Benckiser Inc.
    Parsippany, NJ 07054-0224
    ©RBI 2009



    Relabeling of "Additional Barcode" by:
    Physicians Total Care, Inc.
    Tulsa, OK      74146

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  • PRINCIPAL DISPLAY PANEL - 600 mg Carton

    NDC 54868-5849-0

    Mucinex®D

    600 mg guaifenesin & 60 mg pseudoephedrine HCl
    extended-release bi-layer tablets

    EXPECTORANT & NASAL DECONGESTANT

    12 HOUR

    NEW LOOK-
    SAME RELIEF

    Thins And Loosens Mucus

    Clears Nasal/Sinus Congestion

    18 EXTENDED-RELEASE BI-LAYER TABLETS

    Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    MUCINEX D 
    guaifenesin and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54868-5849(NDC:63824-057)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 600 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER 934  
    FD&C YELLOW NO. 6  
    HYPROMELLOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color orange, white Score no score
    Shape OVAL Size 16mm
    Flavor Imprint Code Mucinex;600
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-5849-0 2 in 1 CARTON
    1 9 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021585 01/07/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel
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