Label: CURANEX DM- dextromethorphan hydrobromide 20 mg guaifenesin 400 mg tablet

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

Drug Label Information

Updated April 4, 2024

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    ■ take with a full glass of water

    ■ adults and children 12 years and over: 1 tablet

    every 4 hours.

    ■ Do not take more than 6 tablets in 24 hours.

    ■ children under 12 years: do not use

    Other information

  • WARNINGS

    Do Not Use ~ you are now taking a prescription

    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

    ■ cough accompanied by too much phlegm (mucus)

    ■ persistent or chronic cough such as occurs~~

    with smoking, asthma, chronic bronchitis,

    or emphysema

    ■When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    ■ cough persists more than 7 days, tends to recur,

    or is accompanied by a fever, rash, or persistent

    headache.

    These could be signs of a serious condition.

    ■ if pregnant or breast-feeding, ask a health

    professional before use.

  • INACTIVE INGREDIENT

    Magnesium Stearate, Microcrystalline Cellulose,

    Sodium Starch Glycolate

  • INDICATIONS & USAGE

    Cough Suppressant and Expectorant

    ■ helps: loosen phlegm (mucus) and thin bronchial

    secretions to rid the bronchial passageways of

    bothersome mucus and make coughs more productive

    ■ temporarily relieves: ■ cough due to minor throat and

    bronchial irritation associated with the common cold

    ■ the intensity of coughing ■ the impulse to cough to

    help you get to sleep

  • 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 (1-800-222-1222) right

    away.

  • PURPOSE

    Purpose

    (In each Immediate-re/ease tablet)

    Dextromethorphan HBr 20 mg ...... Cough suppressant

    Guaifenesin 400 mg ................................. Expectorant

  • ACTIVE INGREDIENT

    Dextromethorphan HBr 20 mg ...... Cough suppressant

    Guaifenesin 400 mg ................................. Expectorant

  • Drug Facts

    Active ingredients Purpose

    (In each Immediate-re/ease tablet)

    Dextromethorphan HBr 20 mg ...... Cough suppressant

    Guaifenesin 400 mg ................................. Expectorant

    Use

    ■ helps: loosen phlegm (mucus) and thin bronchial

    secretions to rid the bronchial passageways of

    bothersome mucus and make coughs more productive

    ■ temporarily relieves: ■ cough due to minor throat and

    bronchial irritation associated with the common cold

    ■ the intensity of coughing ■ the impulse to cough to

    help you get to sleep

    Warnings

    Do Not Use ~ you are now taking a prescription

    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

    ■ cough accompanied by too much phlegm (mucus)

    ■ persistent or chronic cough such as occurs~~

    with smoking, asthma, chronic bronchitis,

    or emphysema

    (Panel 2)

    Warnings (continued)

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    ■ cough persists more than 7 days, tends to recur,

    or is accompanied by a fever, rash, or persistent

    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 overdose, get medical help or contact

    a Poison Control Center (1-800-222-1222) right

    away.

    Directions

    ■ take with a full glass of water

    ■ adults and children 12 years and over: 1 tablet

    every 4 hours.

    ■ Do not take more than 6 tablets in 24 hours.

    ■ children under 12 years: do not use

    Other information

    ■ store between 15°-30°C (59°-86°F)

    Inactive ingredients

    Magnesium Stearate, Microcrystalline Cellulose,

    Sodium Starch Glycolate

    Questions or Comments?

    call 1-352-549-9917, Mon-Fri: 9:00AM - 5:00 PM

    Panel 1

    Panel 2

  • INGREDIENTS AND APPEARANCE
    CURANEX DM 
    dextromethorphan hydrobromide 20 mg guaifenesin 400 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83335-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code DG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83335-004-011 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/01/2023
    Labeler - Wittman Pharma, Inc. (830980947)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wittman Pharma, Inc.830980947manufacture(83335-004)