Label: MUCUS RELIEF- guaifenesin tablet

  • 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 November 20, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:  Each immediate-release tablet contains – Guaifenesin 400 mg

  • PURPOSE

    PURPOSE:  Expectorant

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN:  In case of overdose, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus.

  • WARNINGS

    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 excessive phlegm (mucus)

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older, 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 of age do not use.

  • INACTIVE INGREDIENT

    Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

  • Principal Display Panel

    Muc400Lab3
  • Principal Display Panel

    Muc400Lab6
  • Principal Display Panel

    Muc400Lab9
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58118-9896(NDC:49483-272)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code TCL272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58118-9896-330 in 1 BOTTLE, PLASTIC
    2NDC:58118-9896-660 in 1 BOTTLE, PLASTIC
    3NDC:58118-9896-990 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/23/2012
    Labeler - Clinical Solutions Wholesale (078710347)
    Registrant - Clinical Solutions Wholesale (078710347)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clinical Solutions Wholesale078710347REPACK(58118-9896) , RELABEL(58118-9896)
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