Label: MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 13, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release bi-layer tablet)Purpose
    Dextromethorphan HBr 30 mgCough suppressant
    Guaifenesin 600 mgExpectorant
  • 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
  • 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.

  • 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
  • Other information

    • tamper evident: do not use if carton is damaged or if pouch is broken or torn
    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; D&C Yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

    1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Product Repackaged and Distributed with permission of
    manufacturer by: Select Corporation, Carrollton, TX 75007

    Distributed by: Reckitt Benckiser
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack Carton

    Mucinex® DM

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

    EXPECTORANT & COUGH SUPPRESSANT

    12 HOUR

    ✓ Controls Cough
    ✓ Thins And Loosens Mucus

    20 Pouches –
    2 tablets each

    ← extended-release
    ← immediate-release

    PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX DM 
    guaifenesin and dextromethorphan hydrobromide tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-650(NDC:63824-056)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    guaifenesin (UNII: 495W7451VQ) (guaifenesin - UNII:495W7451VQ) guaifenesin600 mg
    dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide30 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    aluminum oxide (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (yellow and white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-650-031 in 1 BLISTER PACK06/26/2012
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:52904-650-2020 in 1 CARTON06/26/2012
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162006/26/2012
    Labeler - Select Corporation (053805599)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!