Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 6a6f5da8-6433-4284-8df7-2d5b099b74dc
Route
ORAL
Published
Effective Date 2025-05-14
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 Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Polyethylene Glycol, Unspecified Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-04-10

Description

Acetaminophen, 650 mg Dextromethorphan HBr, 20 mg

Purpose

Pain reliever/Fever reducer Cough suppressant


Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant

Description

Acetaminophen, 650 mg Dextromethorphan HBr, 20 mg

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
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 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 50567-7

When using this product do not use more than directed.

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, or emphysema
Section 53414-9

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

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

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
Other Information
  • each 20 mL contains:sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
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.

Inactive Ingredients

anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Principal Display Panel

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE

Cough +

Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

Cough

Sore Throat Pain

Strong Cooling Liquid

Non-Drowsy

POWERFUL

SORE THROAT

Relief

CF

MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Active Ingredients (in Each 20 Ml)

Acetaminophen, 650 mg

Dextromethorphan HBr, 20 mg


Structured Label Content

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
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 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 50567-7 (50567-7)

When using this product do not use more than directed.

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, or emphysema
Section 53414-9 (53414-9)

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

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

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
Other Information (Other information)
  • each 20 mL contains:sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
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.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE

Cough +

Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

Cough

Sore Throat Pain

Strong Cooling Liquid

Non-Drowsy

POWERFUL

SORE THROAT

Relief

CF

MAX

For Ages 12 & Over

4 FL OZ (118 mL)

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

Acetaminophen, 650 mg

Dextromethorphan HBr, 20 mg


Advanced Ingredient Data


Raw Label Data

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