Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID a6f750c8-8738-4965-a3ad-612c24611056
Route
ORAL
Published
Effective Date 2024-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Polyethylene Glycol, Unspecified Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Triacetin Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-15
Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant

Dosage and Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • 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

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Section 42229-5

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Section 44425-7

Other information

  • each 20 mL contains:sodium 14 mg
  • store at 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 51727-6

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, menthol, natural and artificial flavors, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum

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

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Additional Information

Maximum Strength claim based on maximum levels of active ingredients per 4 hour dose.

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE MULTI-SYMPTOM

Cough Cold + Flu CF MAX

Do Not Use if breakable ring on bottle cap is separated or missing.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Distributed by: Haleon, Warren, NJ 07059

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

Trademarks owned or licensed by Haleon.

Pat. Info www.productpats.com

©2023 Haleon or licensor.

Principal Display Panel

ADULT NEW FORMULA HALEON

Robitussin

MAXIMUM STRENGTH

SEVERE

MULTI-SYMPTOM

Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

✓Cough, Sore Throat

✓Head & Body Aches, Fever

✓Chest Congestion

✓Thins & Loosens Mucus

FAST, POWERFUL

multi-symptom relief

CF

MAX

For Ages 12 & Over

8 FL OZ (237 mL)

62000000207716 Front Carton

Active Ingredients (in Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • 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)

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Section 44425-7 (44425-7)

Other information

  • each 20 mL contains:sodium 14 mg
  • store at 20-25°C (68-77°F)
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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, menthol, natural and artificial flavors, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum

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

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Additional Information (Additional information)

Maximum Strength claim based on maximum levels of active ingredients per 4 hour dose.

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE MULTI-SYMPTOM

Cough Cold + Flu CF MAX

Do Not Use if breakable ring on bottle cap is separated or missing.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Distributed by: Haleon, Warren, NJ 07059

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

Trademarks owned or licensed by Haleon.

Pat. Info www.productpats.com

©2023 Haleon or licensor.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT NEW FORMULA HALEON

Robitussin

MAXIMUM STRENGTH

SEVERE

MULTI-SYMPTOM

Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

✓Cough, Sore Throat

✓Head & Body Aches, Fever

✓Chest Congestion

✓Thins & Loosens Mucus

FAST, POWERFUL

multi-symptom relief

CF

MAX

For Ages 12 & Over

8 FL OZ (237 mL)

62000000207716 Front Carton

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

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:16.162503 · Updated: 2026-03-14T23:10:31.490874