Robitussin Maximum Strength Severe Cough Plus Sore Throat Liquid
FDA Label NDC 0031-8750

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Maximum Strength Severe Cough Plus Sore Throat (NDC 0031-8750). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, sore throat warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

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.

    Distributed by: Pfizer, Madison, NJ 07940 USA

Otc - Purpose

Active ingredients (in each 20 ml)Purposes
Acetaminophen, USP 650 mgPain reliever/Fever reducer
Dextromethorphan HBr, USP 20 mgCough suppressant

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

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.

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.

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

Otc - When Using

When using this product do not use more than directed.

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.

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
  • agedose
    adults and children 12 years and over20 ml every 4 hours
    children under 12 yearsdo not use

Other Information

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

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 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 - 118 Ml Bottle Label

ADULT
Robitussin
®

MAXIMUM STRENGTH

SEVERE
Cough +
Sore Throat

CF
MAX

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Strong Cooling Liquid
Non-Drowsy

4 FL OZ (118 ml)

Principal Display Panel - 118 Ml Bottle Carton

New

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)

Principal Display Panel (118 ml Bottle Carton)

Principal Display Panel (118 ml Bottle Carton)

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