GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC]

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GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC]
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NDC 11534-164-01
Set ID 5e3875ba-d34c-48b2-93ec-baa27f6a37a2
Category HUMAN OTC DRUG LABEL
Packager Sunrise Pharmaceutical Inc
Generic Name
Product Class
Product Number
Application Number PART341
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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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