Drug Facts

Drug Facts

SPL v8

SPL

SPL Set ID eaa10aed-5b1e-48bf-bc05-7a5638851daf

Route

ORAL

Published

Effective Date 2024-05-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (400 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Xanthan Gum Zinc Gluconate Honey

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-06-25

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 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

age

dose

adults and children

12 years and over

20 mL every 4 hours

children under 12 years

do not use

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Section 44425-7

Other information

each 20 mL contains: sodium 21 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 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, 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

Section 53413-1

Questions or comments?

call weekdays from 8 AM to 6 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

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

Dist. by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

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

Pat. Info www.productpats.com Made in Canada

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel

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

DM

MAX

For Ages 12+

4 FL OZ (118 mL)

62000000211563 Carton Front

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

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

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 21 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 50570-1 (50570-1)

Section 51727-6 (51727-6)

Inactive ingredients

Section 53413-1 (53413-1)

Questions or comments?

call weekdays from 8 AM to 6 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 (Additional information)

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

Dist. by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

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

Pat. Info www.productpats.com Made in Canada

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

DM

MAX

For Ages 12+

4 FL OZ (118 mL)

62000000211563 Carton Front

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

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM GLUCONATE", "unii": "R6Q3791S76", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC GLUCONATE", "unii": "U6WSN5SQ1Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HONEY", "unii": "Y9H1V576FH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "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", "34071-1": "Warnings", "44425-7": "Other information each 20 mL contains : sodium 21 mg store at 20-25°C (68-77°F). Do not refrigerate.", "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.", "51727-6": "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", "53413-1": "Questions or comments? call weekdays from 8 AM to 6 PM EST at 1-800-245-1040", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Cough suppressant Expectorant", "Additional information": "Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Dist. by: Haleon, Warren, NJ 07059 ©2024 Haleon or licensor. Trademarks owned or licensed by Haleon. For most recent product information, visit www.robitussin.com Pat. Info www.productpats.com Made in Canada PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org", "PRINCIPAL DISPLAY PANEL": "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 DM MAX For Ages 12+ 4 FL OZ (118 mL) 62000000211563 Carton Front", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:02.663842 · Updated: 2026-03-14T23:02:54.359020