Label: MUCINEX DM - guaifenesin and dextromethorphan hydrobromide 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

    600 mg guaifenesin & 30 mg dextromethorphan HBr extended-release bi-layer tablets

    EXPECTORANT & COUGH SUPPRESSANT

    Close
  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release bi-layer tablet) Purpose
    Dextromethorphan HBr 30 mg Cough suppressant
    Guaifenesin 600 mg Expectorant
    Close
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleep
    Close
  • Warnings

    Do not use

    • for children under 12 years of age
    • 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

    • 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

    • cough lasts more than 7 days, comes back, or occurs with 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.

    Close
  • 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: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours
    • children under 12 years of age: do not use
    Close
  • 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)
    Close
  • Inactive ingredients

    carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

    Close
  • 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

    Close
  • PRINCIPAL DISPLAY PANEL - 600 mg Carton

    NDC 54868-5853-0

    Mucinex®DM

    600 mg guaifenesin & 30 mg dextromethorphan HBr
    extended-release bi-layer tablets

    EXPECTORANT & COUGH SUPPRESSANT

    12 HOUR

    NEW LOOK-
    SAME RELIEF

    Thins And Loosens Mucus

    Controls Cough

    20 EXTENDED-RELEASE BI-LAYER TABLETS

    Principal Display Panel

    Close
  • INGREDIENTS AND APPEARANCE
    MUCINEX DM 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54868-5853(NDC:63824-056)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 600 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER 934  
    D&C YELLOW NO. 10  
    HYPROMELLOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color white (yellow and 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:54868-5853-0 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021620 01/23/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel
    Close