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NDC 63548-0109-1
Set ID 9bdab8cf-066e-41d2-891e-134c029c4bb6
Category HUMAN OTC DRUG LABEL
Packager PLD Acquisitions LLC DBA Avéma Pharma Solutions
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each tablet)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
    • temporarily relieves
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • intensity of coughing
      • the impulse to cough to help you get to sleep
  • 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

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough accopanied 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 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

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

    • each tablet contains: sodium 20 mg low sodium
    • store between 20-25ºC (68-77ºF)
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Mucus Relief DM

    Guaifenesin 400 mg

    Expectorant

    Dextromethorphan HBr 20 mg

    Cough suppressant

    • Controls Cough
    • Thins and loosens mucus

    Tablets

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    Manufactured by:

    Avema Pharma Solutions

    10400 NW 29th Terrace

    Miami, FL 33172

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 400 mg

    Mucus Relief DM

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    guaifenesin, dextromethorphan hbr tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0109
    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 CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize17mm
    FlavorImprint Code G2;G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63548-0109-1500 in 1 BOTTLE; Type 0: Not a Combination Product01/02/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/02/2010
    Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)
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