MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]

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MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]
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NDC 59726-109-30
Set ID a36974bc-64b2-4e2d-b98f-2199cda8ae94
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
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

    • 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

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied 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 at 20-25°C (68-77°F)
  • 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

    dextromethorphan HBr 20 mg

    expectorant

    cough suppressant

    • controls cough
    • thins and loosens mucus

    tablets

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY  11590

  • Product Label

    guaifenesin 400 mg dextromethorphan HBr 20 mg

    ReadyInCase mucus relief dm tablets

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    dextromethorphan hydrobromide and guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-109
    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
    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
    ColorWHITEScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code TCL280;G2;G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-109-301 in 1 BOX01/06/201012/30/2022
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/06/201012/30/2022
    Labeler - P & L Development, LLC (800014821)
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