Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 18dcede2-5a38-40fa-93fe-48acdd6a7cf1
Route
ORAL
Published
Effective Date 2023-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)
Inactive Ingredients
Acesulfame Potassium Aspartame Citric Acid Monohydrate D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Honey Maltodextrin Medium-chain Triglycerides Silicon Dioxide Sodium Citrate, Unspecified Form Lecithin, Soybean Sucrose Triacetin Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-01
Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

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
Purposes

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

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.

Directions
  • 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.
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 a 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.
Other Information
  • each packet contains:potassium 5 mg, sodium 21 mg
  • phenylketonurics:contains phenylalanine 14 mg per packet
  • store at controlled room temperature 20 -25 oC (68-77 oF). Protect product from heat and moisture.
Inactive Ingredients

acesulfame potassium, aspartame, citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, honey solids, maltodextrin, medium chain triglycerides, natural flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, triacetin, tribasic calcium phosphate

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

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

©2022 GSK group of companies or its licensor.

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

Questions Or Comments?

1-855-328-5259

Principal Display Panel

THERAFLU

NEW FLAVOR

MULTI-SYMPTOM COLD RELIEF

SEVERE COLD RELIEF

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

DAYTIME FORMULA

Hot liquid therapy

that relieves:

/ Nasal and sinus congestion

/ Cough

/ Sore throat pain

/ Headache

/ Fever

Honey Ginger

6 PACKETS

PA 62000000200567 – Carton Front

When Using This Product
  • do not exceed recommended dosage
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.

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask 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
Active Ingredients (in Each Packet)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

Structured Label Content

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
Purposes

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

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.

Directions
  • 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.
Do Not Use (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 a 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.
Other Information (Other information)
  • each packet contains:potassium 5 mg, sodium 21 mg
  • phenylketonurics:contains phenylalanine 14 mg per packet
  • store at controlled room temperature 20 -25 oC (68-77 oF). Protect product from heat and moisture.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, aspartame, citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, honey solids, maltodextrin, medium chain triglycerides, natural flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, triacetin, tribasic calcium phosphate

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

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

©2022 GSK group of companies or its licensor.

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

Questions Or Comments? (Questions or comments?)

1-855-328-5259

Principal Display Panel

THERAFLU

NEW FLAVOR

MULTI-SYMPTOM COLD RELIEF

SEVERE COLD RELIEF

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

DAYTIME FORMULA

Hot liquid therapy

that relieves:

/ Nasal and sinus congestion

/ Cough

/ Sore throat pain

/ Headache

/ Fever

Honey Ginger

6 PACKETS

PA 62000000200567 – Carton Front

When Using This Product (When using this product)
  • do not exceed recommended dosage
Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children. (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.

If Pregnant Or Breast Feeding, (If pregnant or breast- feeding,)

ask a health professional before use.

Ask Doctor Before Use If You Have (Ask 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
Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.978152 · Updated: 2026-03-14T23:02:37.591705