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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 17, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

    • helps loosen phlegm (mucus)
    • helps thin bronchial secretions to 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

    Adults and children 12 years of age and older:

    • Take with a full glass of water.
    • Take 1 softgel every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
    • Children under 12 years of age: do not use
  • Other information

    • store at 25°C (77°F) excursions between 15° - 30°C (59° - 86°F)
    • keep in a dry place and do not expose to heat
    • you may report side effects to 1-888-333-9792
  • Inactive Ingredients

    FD&C Yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Pack Carton

    NEW

    Well at
    Walgreens

    NDC 0363-9891-30

    WALGREENS PHARMACIST RECOMMENDED‡

    Mucus
    Relief DM

    DM Cough

    Guaifenesin 400 mg / Expectorant
    Dextromethorphan HBr 20 mg /
    Cough Suppressant

    • Controls cough
    • Thins & loosens mucus
    • Easy to swallow

    30 SOFTGELS

    PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    guaifenesin and dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9891
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVAL (OBLONG) Size20mm
    FlavorImprint Code 440
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9891-303 in 1 CARTON
    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 finalpart34108/15/2015
    Labeler - Walgreens (008965063)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PVT LTD677385498MANUFACTURE(0363-9891)
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