Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 4908b326-e1da-44ca-8087-7e41a16c27b0
Route
ORAL
Published
Effective Date 2023-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 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 Sodium Gluconate Sucralose Triacetin Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-01
Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Purpose

Cough suppressant Expectorant

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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
Purpose

Cough suppressant Expectorant

Dosage and Administration

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
Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Section 44425-7

Other information

  • each 20 mL contains:sodium 20 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50569-3

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
Section 50570-1

Do not useif 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.

Section 51727-6

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, sodium gluconate, sucralose, triacetin, xanthan gum

Section 53413-1

Questions or comments?

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

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Cough suppressant

Expectorant

Additional Information

Do Not Use if foil is missing or broken.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Use dosage cup included

Distributed by:

GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information,

visit www.robitussin.com

Trademarks are owned by or licensed to the GSK group of companies.

@2023 GSK group of companies or its licensor.

202887 Front Carton

Principal Display Panel

ADULT

Robitussin

Cough+Chest

Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

FAST, EFFECTIVE

cough relief

DM

For Ages 12 & Over

8 FL OZ (237 mL)

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • each 20 mL contains:sodium 20 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not useif 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.

Section 51727-6 (51727-6)

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, sodium gluconate, sucralose, triacetin, xanthan gum

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Cough suppressant

Expectorant

Additional Information

Do Not Use if foil is missing or broken.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Use dosage cup included

Distributed by:

GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information,

visit www.robitussin.com

Trademarks are owned by or licensed to the GSK group of companies.

@2023 GSK group of companies or its licensor.

202887 Front Carton

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

Robitussin

Cough+Chest

Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

FAST, EFFECTIVE

cough relief

DM

For Ages 12 & Over

8 FL OZ (237 mL)

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

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:56.914867 · Updated: 2026-03-14T23:02:46.668637