Robitussin Severe Multi-symptom Cough Cold Flu Liquid
FDA Label NDC 0031-8751

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 Severe Multi-symptom Cough Cold Flu (NDC 0031-8751). 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, indications & usage, warnings, liver warning, sore throat warning, otc - do not use, otc - ask doctor, 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
Guaifenesin, USP 400 mgExpectorant
Phenylephrine HCl, USP 10 mgNasal decongestant

Indications & Usage

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • sinus congestion and pressure
    • 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

Warnings

Warnings

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.

Otc - 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.

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other oral nasal decongestant or stimulant
  • 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

  • you get nervous, dizzy, or sleepless
  • pain, cough, or nasal congestion 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.

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

Storage And Handling

Other information

  • each 20 ml contains: sodium 14 mg
  • store at 20-25°C (68-77°F)

Inactive Ingredient

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

Otc - Questions

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
Multi-Symptom
Cough Cold + Flu
CF

MAX

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)

4 FL OZ (118 ml)

Principal Display Panel - 118 Ml Bottle Carton

ADULT
NEW!

Robitussin®

MAXIMUM STRENGTH

SEVERE
Multi-Symptom
Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:
✓Cough, Sore Throat
✓Body Aches, Fever
✓Nasal Congestion
✓Chest Congestion

Non-Drowsy

Better Taste!
Treats More
Symptoms*
CF
MAX

For Ages 12 & Over
4 FL OZ (118 ml)

* Please review the disclaimer below.