Label: ROBITUSSIN DAY AND NIGHT COUGH RELIEF DM MAX- dextromethorphan hydrobromide, guaifenesin, doxylamine succinate kit

  • NDC Code(s): 0031-2834-01, 0031-8718-18, 0031-8739-12, 0031-8739-18
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 6, 2025

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  • Active ingredients (in each 20 mL) – Robitussin Maximum Strength Cough+Chest Congestion DM

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

  • Purposes – Robitussin Maximum Strength Cough+Chest Congestion DM

    Cough suppressant

    Expectorant

  • Uses – Robitussin Maximum Strength Cough+Chest Congestion DM

    ▪
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    ▪
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings – Robitussin Maximum Strength Cough+Chest Congestion DM

    Do not use

    if 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 that occurs with too much phlegm (mucus)
    ▪
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    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 condition.

    If pregnant or breast-feeding,

    ask a health processional before use.

    Keep out of reach of children.

  • Directions – Robitussin Maximum Strength Cough+Chest Congestion DM

    do not take more than 6 doses in any 24 hour period

    measure only with dosing cup provided

    keep dosing cup with product

    mL = milliliter

    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use
  • Other information – Robitussin Maximum Strength Cough+Chest Congestion DM

    ▪
    each 20 mL contains: sodium 13 mg
    ▪
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients – Robitussin Maximum Strength Cough+Chest Congestion DM

    anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum

  • Questions or comments? – Robitussin Maximum Strength Cough+Chest Congestion DM

    call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

  • Active ingredients (in each 20 mL) – Robitussin Maximum Strength Nighttime Cough DM

    Dextromethorphan HBr, USP 30 mg

    Doxylamine succinate, USP 12.5 mg

  • Purposes – Robitussin Maximum Strength Nighttime Cough DM

    Cough suppressant

    Antihistamine

  • Uses – Robitussin Maximum Strength Nighttime Cough DM

    ▪
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    ▪
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    ▪
    runny nose
    ▪
    sneezing
    ▪
    itchy, watery eyes
    ▪
    itching of the nose or throat
    ▪
    controls the impulse to cough to help you sleep
  • Warnings – Robitussin Maximum Strength Nighttime Cough DM

    Do not use

    ▪
    to sedate a child or to make a child sleepy
    ▪
    if 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

    ▪
    trouble urinating due to an enlarged prostate gland
    ▪
    glaucoma
    ▪
    a cough that occurs with too much phlegm (mucus)
    ▪
    a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    ▪
    do not use more than directed
    ▪
    marked drowsiness may occur
    ▪
    avoid alcoholic drinks
    ▪
    alcohol, sedatives, and tranquilizers may increase drowsiness
    ▪
    be careful when driving a motor vehicle or operating machinery
    ▪
    excitability may occur, especially in children

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, 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

  • Directions – Robitussin Maximum Strength Nighttime Cough DM

    •
    measure only with dosing cup provided
    •
    keep dosing cup with product
    •
    mL = milliliter
    •
    do not take more than 4 doses in any 24-hour period
    •
    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    20 mL every 6 hours

    children under 12 years

    do not use
  • Other information – Robitussin Maximum Strength Nighttime Cough DM

    ▪
    each 20 mL contains: sodium 14 mg
    ▪
    store at 20-25°C (68-77°F)
  • Inactive ingredients – Robitussin Maximum Strength Nighttime Cough DM

    anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum

  • Questions or comments? – Robitussin Maximum Strength Nighttime Cough DM

    call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

  • Additional information – Robitussin Maximum Strength Day/Night Combination Package

    TAMPER-EVIDENT INNER UNITS:

    Do Not Use if Tamper-Evident feature on either bottle cap is broken or missing. See individual inner cartons and bottle labels for specific Tamper-Evident features.

    4 oz 8 oz Maximum Strength Cough+Chest Congestion DM

    8 oz Maximum Strength Nighttime Cough DM

    Do not take both products within 6 hours of each other.

    STRONG SOOTHING ACTION and fast, powerful cough relief

    PARENTS: Learn about teen medicine abuse

    www.StopMedicineAbuse.org

  • Principal Display Panel – Robitussin Maximum Strength Cough+Chest Congestion DM

    ADULT

    Robitussin

    MAXIMUM STRENGTH

    Cough+Chest Congestion DM

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    GUAIFENESIN (Expectorant)

    ✓
    Controls Cough
    ✓
    Relieves Chest Congestion
    ✓
    Thins & Loosens Mucus

    FAST, EFFECTIVE cough relief

    DM MAX

    For Ages 12 & Over

    4 FL OZ (118 mL)

    Robitussin MS Cough Plus Chest Congestion DM 4 FL OZ
  • Principal Display Panel – Robitussin Maximum Strength Nighttime Cough DM

    ADULT

    Robitussin

    MAXIMUM STRENGTH

    Nighttime Cough DM

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    DOXYLAMINE SUCCINATE (Antihistamine)

    Controls Cough

    Relieves Runny Nose & Sneezing

    FAST, EFFECTIVE cough relief

    DM NIGHTTIME MAX

    For Ages 12 & Over

    8 FL OZ (237 mL)

    Robitussin MS Nighttime Cough DM 8 fl oz
  • Principal Display Panel – Robitussin Maximum Strength Day/Night Combination Package

    DAY&NIGHT COUGH RELIEF

    DM MAX

    ADULT

    INCLUDES TWO 8oz AND ONE 4oz

    Robitussin

    MAXIMUM STRENGTH

    COUGH+CHEST CONGESTION DM

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    GUAIFENESIN (Expectorant)

    ✓
    Controls Cough
    ✓
    Relives Chest Congestion
    ✓
    Thins & Loosens Mucus

    FAST, EFFECTIVE cough relief

    DM MAX

    2 BOTTLES

    1-8 FL OZ (237 mL) / 1-4 FL OZ (118 mL)

    MAXIMUM STRENGTH

    Nighttime Cough DM

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    DOXYLAMINE SUCCINATE (Antihistamine)

    ✓
    Controls Cough
    ✓
    Relieves Runny Nose & Sneezing

    FAST, EFFECTIVE cough relief

    DM NIGHTTIME MAX

    1 BOTTLE

    8 FL OZ (237 mL)

    For Ages 12 & Over

    3 BOTTLES – 20 FL OZ (591 mL) TOTAL

    Robitussin MS Day Night Combo Kit 8 oz 4 oz 8 oz
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN  DAY AND NIGHT COUGH RELIEF DM MAX
    dextromethorphan hydrobromide, guaifenesin, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2834
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-2834-011 in 1 CARTON; Type 0: Not a Combination Product03/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 BOTTLE 391 mL
    Part 21 BOTTLE 237 mL
    Part 1 of 2
    ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Item Code (Source)NDC:0031-8739
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8739-121 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0031-8739-181 in 1 CARTON
    2237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2016
    Part 2 of 2
    ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
    dextromethorphan hydrobromide, doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:0031-8718
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8718-181 in 1 CARTON
    1237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2021
    Labeler - Haleon US Holdings LLC (079944263)
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