Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID e35cb719-9e7d-4b2b-81a4-29e147dd74fa

Route

ORAL

Published

Effective Date 2024-05-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (1000 mg) Dextromethorphan (30 mg) Pseudoephedrine (60 mg)

Inactive Ingredients

Alcohol Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified D&c Red No. 33 Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-19

Description

Acetaminophen 1000 mg Dextromethorphan HBr 30 mg Pseudoephedrine HCl 60 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 1000 mg Dextromethorphan HBr 30 mg Pseudoephedrine HCl 60 mg

Uses

temporarily relieves these symptoms due to a common cold or flu:
- headache
- minor aches and pains
- minor sore throat pain
- cough due to minor throat and bronchial irritation
- nasal and sinus congestion
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
measure the dose correctly using the enclosed dosing cup
adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
children under 12 years of age: do not use

Age	Dose
adults and children 12 years of age and over	30 mL every 6 hours
children under 12 years of age	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 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 30 mL contains: sodium 26 mg
store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.

Inactive Ingredients

alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

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

DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING.

Distributed by: Haleon

Warren, NJ 07059

Made in Canada

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

Pat. Info www.productpats.com

Questions Or Comments?

1-855-328-5259

Principal Display Panel

MULTI-SYMPTOM RELIEF NEWHALEON

THERAFLU-D

FLU RELIEF

MAX STRENGTH*

+ NASAL DECONGESTANT

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Pseudoephedrine HCI

Nasal Decongestant

Fast, Powerful Multi-Symptom relief of:

/ Fever

/ Nasal congestion

/ Sinus Pressure

/ Head & Body Ache

/ Sore Throat Pain

/ Cough

Cherry Flavor

8.0 FL OZ (237 mL)

62000000209289 Carton

When Using This Product

do not exceed recommended dosage

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occurs
pain, cough or nasal congestion 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.

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.

Active Ingredients (in Each 30 Ml)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Pseudoephedrine HCl 60 mg

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
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

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 common cold or flu:
- headache
- minor aches and pains
- minor sore throat pain
- cough due to minor throat and bronchial irritation
- nasal and sinus congestion
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
measure the dose correctly using the enclosed dosing cup
adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist
do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor
children under 12 years of age: do not use

Age	Dose
adults and children 12 years of age and over	30 mL every 6 hours
children under 12 years of age	do not use

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 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 30 mL contains: sodium 26 mg
store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.

Inactive Ingredients (Inactive ingredients)

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

DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING.

Distributed by: Haleon

Warren, NJ 07059

Made in Canada

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

Pat. Info www.productpats.com

Questions Or Comments? (Questions or comments?)

1-855-328-5259

Principal Display Panel

MULTI-SYMPTOM RELIEF NEWHALEON

THERAFLU-D

FLU RELIEF

MAX STRENGTH*

+ NASAL DECONGESTANT

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Pseudoephedrine HCI

Nasal Decongestant

Fast, Powerful Multi-Symptom relief of:

/ Fever

/ Nasal congestion

/ Sinus Pressure

/ Head & Body Ache

/ Sore Throat Pain

/ Cough

Cherry Flavor

8.0 FL OZ (237 mL)

62000000209289 Carton

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
pain, cough or nasal congestion 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Pseudoephedrine HCl 60 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
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

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

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains minor sore throat pain cough due to minor throat and bronchial irritation nasal and sinus congestion 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 measure the dose correctly using the enclosed dosing cup adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL every 6 hours children under 12 years of age 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 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 30 mL contains : sodium 26 mg store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.", "Inactive ingredients": "alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose", "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 DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING. Distributed by: Haleon Warren, NJ 07059 Made in Canada ©2024 Haleon group of companies or its licensor. Trademarks are owned by or licensed to the Haleon group of companies. Pat. Info www.productpats.com", "Questions or comments?": "1-855-328-5259", "Principal Display Panel": "MULTI-SYMPTOM RELIEF NEW HALEON THERAFLU-D FLU RELIEF MAX STRENGTH* + NASAL DECONGESTANT Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Pseudoephedrine HCI Nasal Decongestant Fast, Powerful Multi-Symptom relief of: / Fever / Nasal congestion / Sinus Pressure / Head & Body Ache / Sore Throat Pain / Cough Cherry Flavor 8.0 FL OZ (237 mL) 62000000209289 Carton", "When using this product": "do not exceed recommended dosage", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion 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.", "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.", "Active ingredients (in each 30 mL)": "Acetaminophen 1000 mg Dextromethorphan HBr 30 mg Pseudoephedrine HCl 60 mg", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes glaucoma 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", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:10.980500 · Updated: 2026-03-14T23:03:06.131630