Label: MUCUS RELIEF COUGH AND CONGESTION DM- guaifenesin and dextromethorphan hbr tablet

  • NDC Code(s): 54738-985-30, 54738-985-60
  • Packager: Richmond Pharmaceuticals, 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 October 30, 2017

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  • Active ingredients (in each caplet)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

  • Purpose

    Cough suppressant
    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
    • helps loosen phlegm (mucus) and 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 a doctor before use if you have

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

    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 condition. 

    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.

  • Directions

    • take with a full glass of water
    • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: do not use
  • Other information

    • store at 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

  • Questions or comments?

    call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Principal Display Panel

    Mucus Relief Cough and Congestion DM

    NDC- 54738-985-30....30 caplets

    IMG_4692

    NDC- 54738-985-60....60 caplets

    IMG_4693

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COUGH AND CONGESTION DM 
    guaifenesin and dextromethorphan hbr tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-985
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code AP;150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54738-985-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
    2NDC:54738-985-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2016
    Labeler - Richmond Pharmaceuticals, Inc (043569607)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(54738-985)
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