Label: MUCOSA DM- guaifenesin dextromethorphan tablet

  • NDC Code(s): 49483-280-00, 49483-280-06, 49483-280-20
  • Packager: TIME CAP LABORATORIES, INC.
  • 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 September 18, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each immediate-release tablet)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • PURPOSE

    Purpose

    Cough suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses
    • helps loosen phlegm (mucus)
    • helps thin bronchial secretions to make coughs more productive
    • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

  • WARNINGS

    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 a 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 healthcare professional before use

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: take 1 tablet 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
  • STORAGE AND HANDLING

    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 excessive heat
  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • QUESTIONS

    Questions or comments?

    Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    280R-Timely-200s-label280RLABEL Enter section text here

  • INGREDIENTS AND APPEARANCE
    MUCOSA DM 
    guaifenesin dextromethorphan tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-280
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code TCL280
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-280-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-280-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
    3NDC:49483-280-20200 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/17/2012
    Labeler - TIME CAP LABORATORIES, INC. (037052099)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(49483-280)
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