Theraflu Flu Relief Max Strength Powder
FDA Label NDC 0067-7921

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 Flu Relief Max Strength (NDC 0067-7921). 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 packet), 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 Packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Acetaminophen 1000 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Uses

  • temporarily relieves these symptoms due to a common cold:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
    • temporarily reduces fever
      • temporarily relieves these symptoms due to a common cold:
        • headache
        • minor aches and pains
        • cough due to minor throat and bronchial irritation
        • minor sore throat pain
        • runny nose
        • 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.
    • 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 a MAO, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • liver disease
  • 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
    • liver disease
    • 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 the blood thinning drug warfarin
    • taking sedatives or tranquilizers

When Using This Product

  • 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

  • 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.
    • 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.

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
  • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
    • AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
     
     
     
     
     
     
    • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
      • do not use more than directed
      • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
        • AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
         
         
         
         
         
         
        • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
        • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat

Other Information

  • each packet contains: potassium 10 mg, sodium 20 mg
  • phenylketonurics: contains phenylalanine 19.6 mg per packet
  • store at a controlled room temperature at 20 - 25°C (68-77°F)
    • each packet contains: potassium 5 mg, sodium 22 mg
    • phenylketonurics: contains phenylalanine 12.9 mg per packet
    • store at a controlled room temperature at 20 - 25°C (68-77°F)

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C

red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10,

FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions Or Comments?

call 1-800-328-5259

call 1-800-328-5259

Other Safety Information

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

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

*Maximum Strength per 6 hour dose

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

1-855-328-5259

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

©2022 GSK group of companies or its licensor.

CM20324

Principal Display Panel

NDC 0067-7923-02

THERAFLU

FLU RELIEF

MAX STRENGTH*

USE ONLY AS DIRECTED

6 x DAYTIME

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

6 x NIGHTTIME

Acetaminophen Pain Reliever/Fever Reducer

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Cough Suppressant

Hot liquid therapy that relieves:

/ Fever

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

/ Runny nose (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon

  •  CM20324 Front Carton
    • Theraflu Flu Relief Dt Nt Powder 12ct (Image 01)

    Theraflu Flu Relief Dt Nt Powder 12ct (Image 01)

* Please review the disclaimer below.