Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b43d8fbd-1977-4465-aa64-79e7b7f54e09
Route
ORAL
Published
Effective Date 2025-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Doxylamine (30 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Dextrose, Unspecified Form Menthol, Unspecified Form Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sucralose Triacetin Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01
Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg

Purpose

Cough suppressant Expectorant

Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg

Uses
  • 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
Purposes

Cough suppressant

Expectorant

Directions
  • 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
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.

Other Information
  • each 20 mL contains:sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients

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

Additional Information

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.

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

Questions Or Comments?

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

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 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 right away.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

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

DMNIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Principal Display Panel – Robitussin Maximum Strength Day/night Value Pack

DAY&NIGHT VALUE PACK

ADULT

Robitussin

MAXIMUM STRENGTH

COUGH+CHEST CONGESTION DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

FAST, EFFECTIVEcough relief

DMMAX

For Ages 12 & Over

4 FL OZ (118 mL)

MAXIMUM STRENGTH

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

  • Controls Cough
  • Relieves Runny Nose & Sneezing

FAST, EFFECTIVEcough relief

DMNIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

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, EFFECTIVEcough relief

DMMAX

For Ages 12 & Over

4 FL OZ (118 mL)

Structured Label Content

Uses
  • 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
Purposes

Cough suppressant

Expectorant

Directions
  • 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
Do Not Use (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.

Other Information (Other information)
  • each 20 mL contains:sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

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

Additional Information (Additional information)

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.

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Ask A Doctor Before Use If You Have (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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Principal Display Panel – Robitussin Maximum Strength Nighttime Cough Dm (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

DMNIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Principal Display Panel – Robitussin Maximum Strength Day/night Value Pack (Principal Display Panel – Robitussin Maximum Strength Day/Night Value Pack)

DAY&NIGHT VALUE PACK

ADULT

Robitussin

MAXIMUM STRENGTH

COUGH+CHEST CONGESTION DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

FAST, EFFECTIVEcough relief

DMMAX

For Ages 12 & Over

4 FL OZ (118 mL)

MAXIMUM STRENGTH

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

  • Controls Cough
  • Relieves Runny Nose & Sneezing

FAST, EFFECTIVEcough relief

DMNIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Principal Display Panel – Robitussin Maximum Strength Cough+chest Congestion Dm (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, EFFECTIVEcough relief

DMMAX

For Ages 12 & Over

4 FL OZ (118 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:59.731605 · Updated: 2026-03-14T23:13:32.363247