Label: MUCUS RELIEF DM- dextromethorphan hbr 20mg guaifenesin 400mg tablet

  • NDC Code(s): 72090-027-01
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 4, 2024

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

  • Active Ingredient (in each tablet)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400mg

  • Purpose

    Dextromethorphan HBr 20 mg ......................................... Cough suppressant
    Guaifenesin 400mg ........................................................................ Expectorant

  • USES:

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

  • WARNINGS:

  • Do not use

    • for children under 12 year 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 sign of serious illness.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222).

  • DIRECTIONS:

    Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 hours.

    Children under 12 years of age: Do not use

  • OTHER INFORMATION: 

    Store between 20ºC-25ºC (68ºF-77ºF).

    • Keep in a dry place and do not expose to heat 
    • do not use if imprinted safety seal under cap is broken or missing.
  • INACTIVE INGREDIENTS:

    microcrystalline cellulose, sodium starch glycolate, stearic acid powder, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, D&C yellow

  • QUESTIONS OR COMMENTS?

    Call (732) 698-5070 Monday through Friday 9 AM to 5 PM EST or www.pioneerlifesciences.com

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Reckitt Benckiser’s, owner of the registered trademark MUCINEX DM® Tablets.

  • SPL UNCLASSIFIED SECTION

    Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816

  • PRINCIPAL DISPLAY PANEL

    PL0126 - Mucus Relief DM 200ct-Elysium 08.09.2023

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    dextromethorphan hbr 20mg guaifenesin 400mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-027
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    microcrystalline cellulose (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code ET16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-027-01150 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/04/2024
    Labeler - Pioneer Life Sciences, LLC (014092742)