Label: MUCUS RELIEF DM- guaifenesin and dextromethorphan hydrobromide capsule, liquid filled

  • NDC Code(s): 68210-4153-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)Purposes
    Guaifenesin 400mgExpectorant
    Dextromethorphan HBr 20mgCough Suppressant
  • Uses

    • temporarily relieves cough due to minor throat and
      bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial
      secretions to rid the bronchial passageways of
      bothersome mucus and make coughs more productive
  • 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 Doctor before use if you have

    • cough accompanied by excessive phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

    When using this product

    • do not exceed recommended dosage
    • do not use for more than 7 days

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

    Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center right away.

    Directions

    • do not exceed 6 doses in 24 hours
    • take with a full glass of water
    • adults and children 12 years of age and over: take 1 softgel every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°- 30°C (59° - 86°F)
    • keep in a dry place and do not expose to heat
  • Inactive Ingredients

    gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Mucus relief DM
    Dextromethorphan HBr 20 mg- cough suppressant

    Guaifenesin 400 mg - expectorant

    • Controls Cough • Thins & Loosens Mucus


    10 Softgels

    image description

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    guaifenesin and dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4153
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Coloryellow (LOGHT YELLOW) Scoreno score
    ShapeOVAL (OBLONG) Size20mm
    FlavorImprint Code 440;901
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4153-11 in 1 BLISTER PACK04/29/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/29/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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