Label: EQUALINE MUCUS DM- dextromethorphan hbr, guaifenesin tablet, extended release

  • NDC Code(s): 41163-781-66
  • Packager: United Natural Foods, Inc. dba UNFI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 2, 2023

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

  • Active ingredients (in each extended-release tablet)

    Dextromethorphan HBr 60 mg

    Guaifenesin 1200 mg

  • Purposes

    Cough suppressant

    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:
    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 (1-800-222-1222).

  • 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 tablet every 12 hours; not more than 2 tablets in 24 hours
    children under 12 years of age: do not use
  • Other information

    each tablet contains: magnesium 25 mg
    do not use if printed foil under cap is broken or missing
    store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

    1-855-423-2630

  • Package/Label Principal Display Panel

    compare to Maximum Strength Mucinex® DM active ingredients

    maximum strength

    mucus-DM

    guaifenesin 1200mg/

    dextromethorphan

    hydrobromide 60mg

    extended-release tablets

    (expectorant/

    cough suppressant)

    12 hour

    controls cough

    thins and loosens mucus

    actual size

    14 extended-release tablets

    812EL-mucus-dm.jpg
  • INGREDIENTS AND APPEARANCE
    EQUALINE MUCUS DM 
    dextromethorphan hbr, guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-781
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOW (light) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code L812
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-781-661 in 1 CARTON02/24/2020
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20760202/24/2020
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)