Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (200 mg)

Inactive Ingredients

Fd&c Red No. 40 Gelatin, Unspecified Glycerin Light Mineral Oil Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: R Shape: oval Color: red Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-05-23 Until 2018-12-31

Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 200 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

Distributed by: Pfizer, Madison, NJ 07940 USA

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 53414-9

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

Purposes

Cough suppressant

Expectorant

Directions

•
do not take more than 12 capsules in any 24-hour period
•
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	2 capsules every 4 hours
children under 12 years	do not use

Other Information

•
store at 20-25°C (68-77°F).
•
avoid excessive heat above 40°C (104°F).

Inactive Ingredients

FD&C Red No. 40, gelatin, glycerin, light mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Made in Canada

For most recent product information, visit www.robitussin.com

Principal Display Panel

ADULT

Robitussin^®

MAXIMUM

STRENGTH

Cough+Chest

Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

DM

MAX

Relieves:

•
Cough
•
Mucus

Non-Drowsy

For Ages 12 & Over

20

LIQUID-FILLED

CAPSULES

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

Active Ingredients (in Each Liquid Filled Capsule)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

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)

Distributed by: Pfizer, Madison, NJ 07940 USA

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 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 12 capsules in any 24-hour period
•
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	2 capsules every 4 hours
children under 12 years	do not use

Other Information (Other information)

•
store at 20-25°C (68-77°F).
•
avoid excessive heat above 40°C (104°F).

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, gelatin, glycerin, light mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Made in Canada

For most recent product information, visit www.robitussin.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

Robitussin^®

MAXIMUM

STRENGTH

Cough+Chest

Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

DM

MAX

Relieves:

•
Cough
•
Mucus

Non-Drowsy

For Ages 12 & Over

20

LIQUID-FILLED

CAPSULES

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

Active Ingredients (in Each Liquid Filled Capsule) (Active ingredients (in each liquid-filled capsule))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Distributed by: Pfizer, Madison, NJ 07940 USA", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "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.", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Cough suppressant Expectorant", "Directions": "• do not take more than 12 capsules in any 24-hour period • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 capsules every 4 hours children under 12 years do not use", "Other information": "• store at 20-25°C (68-77°F). • avoid excessive heat above 40°C (104°F).", "Inactive ingredients": "FD&C Red No. 40, gelatin, glycerin, light mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution", "Questions or comments?": "call weekdays from 9 AM to 5 PM EST at 1-800-762-4675 Made in Canada For most recent product information, visit www.robitussin.com", "PRINCIPAL DISPLAY PANEL": "ADULT Robitussin ® MAXIMUM STRENGTH Cough+Chest Congestion DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) DM MAX Relieves: • Cough • Mucus Non-Drowsy For Ages 12 & Over 20 LIQUID-FILLED CAPSULES", "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", "Active ingredients (in each liquid-filled capsule)": "Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 200 mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information