Label: GUIAFENESIN 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 July 29, 2013

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  • OTC - ACTIVE INGREDIENT

    Guaifenesin  400 mg.

  • OTC - PURPOSE

    Expectorant.

  • INDICATIONS AND USAGE

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

  • WARNINGS

    Ask a doctor before use if you have

    Cough that lasts or chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    Cough accompanied by too much phlegm (mucus)

  • OTC - STOP USE  AND ASK A DOCTOR IF

    Cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

  • OTC – IF PREGNANT OR BREAST FEEDING

    Ask a health professional before use.

  • OTC - 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 glass of water

    Adults and children 12 years and over1 tablet every 4 hour. Max 6 doses
    Children 6 to under 12 yearsDo not use
    Children under 6 yearsDo not use
  • OTHER INFORMATION

    Store at 15(-30(C(59(-86(F)

  • INACTIVE INGREDIENT

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    252a4044-figure-01
  • INGREDIENTS AND APPEARANCE
    GUIAFENESIN 
    guiafenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-164
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code TCL;272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11534-164-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/08/2005
    Labeler - Sunrise Pharmaceutical Inc (168522378)
    Registrant - Sunrise Pharmaceutical Inc (168522378)
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