Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant Syrup
FDA Label NDC 0067-0115

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 Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant (NDC 0067-0115). 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 active ingredients (in each 30 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 30 Ml)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Pseudoephedrine HCl 60 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a common cold or flu:
    • headache
    • minor aches and pains
    • minor sore throat pain
    • cough due to minor throat and bronchial irritation
    • nasal and sinus congestion
    • temporarily reduces fever

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • 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.

      • 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

  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin

When Using This Product

  • do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occurs
  • 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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 use more than directed
  • measure the dose correctly using the enclosed dosing cup
  • adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
  • do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
  • children under 12 years of age: do not use
    • Age
    • Dose
    • adults and children 12 years of age and over
    • 30 mL every 6 hours
    • children under 12 years of age
    • do not use

Other Information

  • each 30 mL contains: sodium 26 mg
  • store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.

Inactive Ingredients

alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions Or Comments?

1-855-328-5259

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING.

Distributed by: Haleon

Warren, NJ 07059

Made in Canada

©2024 Haleon group of companies or its licensor.

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

Pat. Info www.productpats.com

Principal Display Panel

MULTI-SYMPTOM RELIEF NEWHALEON

THERAFLU-D

FLU RELIEF

MAX STRENGTH*

+ NASAL DECONGESTANT

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Pseudoephedrine HCI

Nasal Decongestant

Fast, Powerful Multi-Symptomrelief of:

/ Fever

/ Nasal congestion

/ Sinus Pressure

/ Head & Body Ache

/ Sore Throat Pain

/ Cough

Cherry Flavor

8.0 FL OZ (237 mL)

62000000209289 Carton

* Please review the disclaimer below.