MUCUS RELIEF COUGH AND CONGESTION DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [ADVANCE PHARMACEUTICAL INC.]

MUCUS RELIEF COUGH AND CONGESTION DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [ADVANCE PHARMACEUTICAL INC.]
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NDC 17714-150-60
Set ID e507a84a-59d5-47f2-a2df-f342e4b093b4
Category HUMAN OTC DRUG LABEL
Packager Advance Pharmaceutical Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • 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 631-981-4600, 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 17714-150-60

    gaui DM 150-60.jpg

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF COUGH AND CONGESTION DM 
    guaifenesin and dextromethorphan hbr tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-150
    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:17714-150-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2017
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-150)

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