Label: CURNEX- guaifenesin 400mg tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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  • DOSAGE & ADMINISTRATION

    Directions

    • take with full glass of water
    • do not exceed 6 doses in 24 hours

    • Adults and children 12 years of age and over; take 1 tablet every 4 hours while symptoms persist
    • Children under 12 years of age; do not use

  • WARNINGS

    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)

    Stop use and ask a doctor if * cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious illness.

    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.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

  • INDICATIONS & USAGE

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageways of bothersome mucus
  • 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.

  • PURPOSE

    Purpose: Expectorant

  • ACTIVE INGREDIENT

    Guaifenesin 400 mg

  • PRINCIPAL DISPLAY PANEL

    CuraNEX Label

  • INGREDIENTS AND APPEARANCE
    CURNEX 
    guaifenesin 400mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83335-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code GN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83335-003-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2024
    Labeler - Wittman Pharma, Inc. (830980947)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wittman Pharma, Inc.830980947analysis(83335-003) , manufacture(83335-003) , label(83335-003)
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