Theraflu Multi-symptom Severe Cold And Theraflu Nighttime Severe Cold And Cough Kit
FDA Label NDC 0067-8200

17 label sections · Submitted to the FDA by Haleon Us Holdings Llc · 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 Multi-symptom Severe Cold And Theraflu Nighttime Severe Cold And Cough (NDC 0067-8200). 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
        • 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 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.
    • Age
    • Dose
    • adults and children 12 years of age and over
    • one packet
    • children under 12 years of age
    • do 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 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
        • Age
        • Dose
        • adults and children 12 years of age and over
        • one packet
        • children under 12 years of age
        • do 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

Additional Information

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

©2019 GSK group of companies or its licensor.

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

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.

Principal Display Panel

NDC 0067-7919-12

THERAFLU

MULTI-SYMPTOM SEVERE COLD

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

  • Cough
  • Nasal Congestion
  • Sore Throat Pain
  • Headache
  • Body Ache
  • Fever

    • TEA INFUSIONS

    GREEN TEA & HONEY LEMON FLAVORS

    MULTI-SYMPTOM 6 PACKETS

    NIGHTTIME

    SEVERE COLD & COUGH

    Acetaminophen

    Pain Reliever/Fever Reducer

    Diphenhydramine HCl

    Antihistamine/Cough Suppressant

    Phenylephrine HCl

    Nasal Decongestant

    • Cough
    • Nasal Congestion
    • Sore Throat Pain
    • Headache
    • Body Ache
    • Fever
    • Runny Nose
    • Sneezing

      • HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS

      NIGHTTIME 6 PACKETS

      USE AS DIRECTED

      12 TOTAL PACKETS

      gsk

      13469

      Theraflu Multi-symptom Severe Cold And Night Severe Cold & Cough Copack 12 Count Carton. (Image 01)

      Theraflu Multi-symptom Severe Cold And Night Severe Cold & Cough Copack 12 Count Carton. (Image 01)

      NDC 0067-8200-01

      THERAFLU

      MULTI-SYMPTOM SEVERE COLD

      Acetaminophen

      Pain Reliever/Fever Reducer

      Dextromethorphan HBr

      Cough Suppressant

      Phenylephrine HCl

      Nasal Decongestant

      • Cough
      • Nasal Congestion
      • Sore Throat Pain
      • Headache
      • Body Ache
      • Fever

        • TEA INFUSIONS

        GREEN TEA & HONEY LEMON FLAVORS

        MULTI-SYMPTOM 18 PACKETS

        NIGHTTIME

        SEVERE COLD & COUGH

        Acetaminophen

        Pain Reliever/Fever Reducer

        Diphenhydramine HCl

        Antihistamine/Cough Suppressant

        Phenylephrine HCl

        Nasal Decongestant

        • Cough
        • Nasal Congestion
        • Sore Throat Pain
        • Headache
        • Body Ache
        • Fever
        • Runny Nose
        • Sneezing

          • HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS

          NIGHTTIME 6 PACKETS

          USE AS DIRECTED

          24 TOTAL PACKETS

          gsk

          13471

          Theraflu Multi-symptom Severe Cold And Nighttime Severe Cold & Cough Copack 24 Count Carton (Image 02)

          Theraflu Multi-symptom Severe Cold And Nighttime Severe Cold & Cough Copack 24 Count Carton (Image 02)

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