Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1bbd0157-06e6-4a3b-bac9-91ac879ba089
Route
ORAL
Published
Effective Date 2025-11-06
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 Glycerin Honey Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Xanthan Gum Zinc Gluconate Lactic Acid, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-30

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 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

Warnings

Click here to enter Warnings

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 MOAI 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 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions Or Comments?

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

Principal Display Panel

ADULT

Robitussin

Honey

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves runny nose and sneezing

Taste the Real Honey

DMNIGHTTIME MAX

For Ages 12+

4 FL OZ (118 mL)

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 20 mg

Guaifenesin 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

Additional Information – Robitussin Honey Dm Day Night Value Pack

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

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

ADULT

Robitussin

Honey

This dynamic duo combines the great taste of natural honey you want with the powerful, effective cough relief you need.

Made with RealHONEY

TRUE SOURCE CERTIFIED HONEY

Gluten Free

No Artificial Colors

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Robitussin Honey Dm Day Night Value Pack

DAY NIGHT VALUE PACK

ADULT

Robitussin

Honey

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & loosens Mucus

Taste the Real Honey

DMMAX

For Ages 12+

4 FL OZ (118 mL)

ADULT

Robitussin

Honey

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves runny nose and sneezing

Taste the Real Honey

DMNIGHTTIME MAX

For Ages 12+

4 FL OZ (118 mL)

Principal Display Panel – Robitussin Honey Maximum Strength Cough + Chest Congestion Dm

ADULT

Robitussin

Honey

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & loosens Mucus

Taste the Real Honey

DMMAX

For Ages 12+

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

Warnings

Click here to enter Warnings

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 MOAI 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 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

ADULT

Robitussin

Honey

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves runny nose and sneezing

Taste the Real Honey

DMNIGHTTIME MAX

For Ages 12+

4 FL OZ (118 mL)

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 20 mg

Guaifenesin 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

Additional Information – Robitussin Honey Dm Day Night Value Pack (Additional Information – Robitussin Honey DM Day Night Value Pack)

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

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

ADULT

Robitussin

Honey

This dynamic duo combines the great taste of natural honey you want with the powerful, effective cough relief you need.

Made with RealHONEY

TRUE SOURCE CERTIFIED HONEY

Gluten Free

No Artificial Colors

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Robitussin Honey Dm Day Night Value Pack (Principal Display Panel – Robitussin Honey DM Day Night Value Pack)

DAY NIGHT VALUE PACK

ADULT

Robitussin

Honey

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & loosens Mucus

Taste the Real Honey

DMMAX

For Ages 12+

4 FL OZ (118 mL)

ADULT

Robitussin

Honey

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves runny nose and sneezing

Taste the Real Honey

DMNIGHTTIME MAX

For Ages 12+

4 FL OZ (118 mL)

Principal Display Panel – Robitussin Honey Maximum Strength Cough + Chest Congestion Dm (Principal Display Panel – Robitussin Honey Maximum Strength Cough + Chest Congestion DM)

ADULT

Robitussin

Honey

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & loosens Mucus

Taste the Real Honey

DMMAX

For Ages 12+

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

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