Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7
Route
ORAL
Published
Effective Date 2025-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 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 2016-06-01

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
Section 42229-5

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

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 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 53414-9

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

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

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

Questions Or Comments?

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

Principal Display Panel

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)

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

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
Section 42229-5 (42229-5)

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

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 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 53414-9 (53414-9)

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

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

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

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

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)

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

Advanced Ingredient Data


Raw Label Data

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