MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR TABLETS) TABLET [HEALTHLIFE OF USA LLC]

MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR TABLETS) TABLET [HEALTHLIFE OF USA LLC]
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NDC 69517-120-12
Set ID 53d4d306-3175-49e3-8c30-eae71a332f09
Category HUMAN OTC DRUG LABEL
Packager Healthlife of USA LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

    Immediate Release Mucus Relief DM 

  • Active Ingredients 

    • Guaifenesin 400mg
    • Dextromethorphan HBr 15mg 
  • Purpose 

    Expectorant, Cough Suppressant 

  • Uses

    • Helps loosen phlegm (mucus)
    • Helps thin bronchial secretions to make coughs more productive
    • Temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold 
  • Warnings

    Do not use: 

    • If you are now taking a prescriprion 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 

    • Persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • Cough accompanied by excessive phlegm (mucus)
  • Ask a doctor or pharmacist before use if you are

    • Taking sedatives or Tranquilizers
  • When using this product

    • Do not exceed recommended dosage
    • Do ot 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 persistant 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 overdosage, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and over: 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: Do not use
  • Other Information

    • Each Tablet contains: sodium 1.24 mg VERY LOW SODIUM
    • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
    • Keep in a dry place and do not expose to heat
    • Read all product information before using 
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    • Colloidal silicon dioxide
    • Magnesium stearate
    • Microcrystalline Cellulose
    • Sodium starch glycolate
  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

  • Immediate Release Mucus Relief DM Guaifenesin 400mg / Expectorant Dextromethorphan HBr 15 mg/ Cough Suppressant  Controls Cough Thins and Loosens Mucus 12 Tablets  Distributed by: Healthlife of USA LLC Rahway NJ 07065 www.healthlifeofusa.com

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF DM 
    guaifenesin, dextromethorphan hbr tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-120
    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 HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-120-121 in 1 CARTON05/31/2017
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/31/2017
    Labeler - Healthlife of USA LLC (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Limited915664486manufacture(69517-120) , pack(69517-120)

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