Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 036162c9-f5a6-418e-bd5e-ebd72097d27d
Route
ORAL
Published
Effective Date 2023-01-25
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 Glycerin Menthol, Unspecified Form Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Triacetin Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-16

Description

Active ingredients (in each 20 ml) Purposes Dextromethorphan HBr, USP 20 mg Cough suppressant Guaifenesin, USP 200 mg 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
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

Active ingredients (in each 20 ml) Purposes Dextromethorphan HBr, USP 20 mg Cough suppressant Guaifenesin, USP 200 mg Expectorant

Section 42229-5

Distributed by:

Pfizer, Madison, NJ 07940 US

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 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.

Section 50570-1

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.

Section 51727-6

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, 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 1-800-762-4675

Section 53414-9

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

Section 55105-1
Active ingredients (in each 20 ml) Purposes

Dextromethorphan HBr, USP 20 mg

Cough suppressant

Guaifenesin, USP 200 mg

Expectorant

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
Principal Display Panel 118 Ml Bottle Carton

ADULT

See

New

Dosing

Robitussin ®

SUGAR-FREE

DYE-FREE

Cough+Chest

Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

  • 1.
    Controls Cough
  • 2.
    Relieves Chest Congestion
  • 3.
    Thins & Loosens Mucus

Specially Formulated

for DIABETICS

Non-Drowsy

DM

SUGAR-FREE

DYE-FREE

BETTER

TASTING!

Same Effective

Cough Relief*

For Ages 12 & Over

4 FL OZ

(118 ml)


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 42229-5 (42229-5)

Distributed by:

Pfizer, Madison, NJ 07940 US

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 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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, 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 1-800-762-4675

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 20 ml) Purposes

Dextromethorphan HBr, USP 20 mg

Cough suppressant

Guaifenesin, USP 200 mg

Expectorant

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
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton)

ADULT

See

New

Dosing

Robitussin ®

SUGAR-FREE

DYE-FREE

Cough+Chest

Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

  • 1.
    Controls Cough
  • 2.
    Relieves Chest Congestion
  • 3.
    Thins & Loosens Mucus

Specially Formulated

for DIABETICS

Non-Drowsy

DM

SUGAR-FREE

DYE-FREE

BETTER

TASTING!

Same Effective

Cough Relief*

For Ages 12 & Over

4 FL OZ

(118 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)