Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 77be57fb-0ae5-4fad-97f3-b6a4b57383a9
Route
ORAL
Published
Effective Date 2025-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Honey Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Xanthan Gum Zinc Gluconate

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-15

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr 20 mg

Purpose

Pain reliever/Fever reducer Cough suppressant


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 pain
    • headache
  • temporarily reduces fever
Purpose

Pain reliever/Fever reducer Cough suppressant

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, USP 650 mg Dextromethorphan HBr 20 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 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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50567-7

When using this product do not use more than directed.

Section 51727-6

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & 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

Pain reliever/Fever reducer

Cough suppressant

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.
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

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

Distributed by: Haleon, Warren, NJ 07059

©2024 Haleon group of companies or its licensor.

Trademarks are owned by or licensed to the Haleon group of companies.

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

Pat. Info www.productpats.com

Made in Canada

Principal Display Panel

Robitussin

Honey

ADULT

SEVERE

Cough, Flu +

Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

NON-DROWSY

MAXIMUM STRENGTH

  • Controls Cough
  • Soothes Sore Throat Pain
  • Relieves Fever & Body Aches

Taste the Real Honey

with Elderberry

CF

MAX

For Ages 12+

8 FL OZ (237 mL)

62000000207916 – Front Carton

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.
Active Ingredients (in Each 20 Ml)

Acetaminophen, USP 650 mg

Dextromethorphan HBr 20 mg

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, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

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 pain
    • headache
  • temporarily reduces fever
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 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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50567-7 (50567-7)

When using this product do not use more than directed.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & 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 (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

Do Not Use (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.
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)

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

Distributed by: Haleon, Warren, NJ 07059

©2024 Haleon group of companies or its licensor.

Trademarks are owned by or licensed to the Haleon group of companies.

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

Pat. Info www.productpats.com

Made in Canada

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Robitussin

Honey

ADULT

SEVERE

Cough, Flu +

Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

NON-DROWSY

MAXIMUM STRENGTH

  • Controls Cough
  • Soothes Sore Throat Pain
  • Relieves Fever & Body Aches

Taste the Real Honey

with Elderberry

CF

MAX

For Ages 12+

8 FL OZ (237 mL)

62000000207916 – Front Carton

Stop Use and Ask A Doctor If (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.
Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen, USP 650 mg

Dextromethorphan HBr 20 mg

Ask A Doctor Before Use If You Have (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, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)