Theraflu Expressmax Syrup
FDA Label NDC 0067-8129

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 Expressmax (NDC 0067-8129). 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 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Pain Reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
      • temporarily relieves these symptoms due to a cold:
        • minor aches and pains
        • minor sore throat pain
        • headache
        • nasal and sinus congestion
        • runny nose
        • sneezing
        • itchy nose or throat
        • itchy, watery eyes due to hay fever
        • cough due to minor throat and bronchial irritation
        • 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.

      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.
    • 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.
    • with any other product containing diphenhydramine, even one used on the skin
    • 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 and MAO, 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
  • 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
    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • 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
    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

When Using This Product

  • do not exceed recommended dosage
    • do not exceed recommended dosage
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, cough or nasal congestion gets worse or last more than 7 days
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • 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.

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.

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
  • take every 4 hours in dosing cup provided, while symptoms persist
  • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
    • AgeDoseadults and children 12 years of age and over30 mLchildren under 12 years of agedo not use
     
     
     
     
     
     
    • do not use more than directed
    • measure the dose correctly using the enclosed dosing cup
    • take every 4 hours in dosing cup provided, while symptoms persist.
    • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
      • AgeDoseadults and children 12 years of age and over30 mLchildren under 12 years of ageDo not use
       
       
       
       
       
       

Other Information

  • each 30 mL contains: potassium 25 mg, sodium 17 mg
  • store at controlled room temperature 20-25°C (68-77°F)
    • each 30 mL contains: potassium 25 mg, sodium 16 mg
    • store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions Or Comments?

call 1-800-452-0051

Questions?

1-800-452-0051

Principal Display Panel

NDC 0067-8125-16

THERAFLU®

ExpressMax™

VALUE PACK

Use Only as Directed

Alcohol Content: 10%

DAYTIME

NIGHTTIME

2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER-EVIDENT INNER UNIT.

DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING

Distributed by:

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

©2015

12045

NDC 0067-8127-08

THERAFLU®

ExpressMax™

DAYTIME

BERRY FLAVOR

SEVERE COLD & COUGH

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr-COUGH SUPPRESSANT

PHENYLEPHRINE HCl-NASAL DECONGESTANT

•NASAL CONGESTION • SORE THORAT PAIN •COUGH

•BODY ACHE • HEADACHE •FEVER

8.3 FL OZ (245.5mL)

Alcohol Content: 10%

NDC 0067-8129-08

THERAFLU®

ExpressMax™

NIGHTTIME

BERRY FLAVOR

SEVERE COLD & COUGH

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBl-ANTIHISTAMINE/COUGH SUPPRESSANT

PHENYLEPHRINE HCl-NASAL DECONGESTANT

•NASAL CONGESTION • HEADACHE • SORE THORAT PAIN

•RUNNY NOSE • BODY ACHE • COUGH •FEVER

8.3 FL OZ (245.5mL)

Alcohol Content: 10%

* Please review the disclaimer below.