Theraflu Powder, For Solution
FDA Label NDC 0067-6426

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 (NDC 0067-6426). 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 500 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
      • headache
      • runny nose
      • itchy nose or throat
      • cough due to minor throat and bronchial irritation
      • minor sore throat pain
      • nasal and sinus congestion
      • sneezing
      • itchy watery eyes due to hay fever
      • 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 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
  • 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 lasts 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
  • take every 4 hours, while symptoms persist. Do not take more than 6 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. Consumer 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 4 hours, while symptoms persist. Do not take more than 5 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 19 mg
  • phenylketonurics: contains phenylalanine 20 mg per packet
  • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
    • each packet contains: potassium 10 mg, sodium 23 mg
    • phenylketonurics: contains phenylalanine 13 mg per packet
    • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no.1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, 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, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions Or Comments?

call 1-855-328-5259

Call 1-855-328-5259

Principal Display Panel

THERAFLU

MULTI-SYMPTOM SEVERE COLD

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

  • NASAL CONGESTION
  • SORE THROAT PAIN
  • COUGH
  • HEADACHE
  • BODY ACHE
  • FEVER

    • TEA INFUSIONS

    GREEN TEA & HONEY LEMON FLAVORS

    6 MULTI-SYMPTOM PACKETS

    NIGHTTIME SEVERE COLD & COUGH

    ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

    DIPHENHYDRAMINE HCl - ANTIHISTAMINE/COUGH SUPRESSSANT

    PHENYLEPHRINE HCl – NASAL DECONGESTANT

    • NASAL CONGESTION
    • SORE THROAT PAIN
    • COUGH
    • HEADACHE
    • BODY ACHE
    • FEVER
    • RUNNY NOSE
    • SNEEZING

      • Honey Lemon, Chamomile & White Tea Flavors

      6 NIGHTTIME PACKETS

      12 TOTAL PACKETS

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

      DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 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 MULTI-SYMPTOM PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

      DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

      PARENTS: Learn about teen medicine abuse

      www.StopMedicineAbuse.org

      TAMPER-EVIDENT INNER UNIT.

      DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

      1-855-328-5259

      Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

      ©2017 GSK group of companies or its licensor.

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      13215_theraflu Ms Sc & Theraflu Nt Scc Combo_12 Ct.jpg (Image 01)

      13215_theraflu Ms Sc & Theraflu Nt Scc Combo_12 Ct.jpg (Image 01)

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