drug facts

drug facts

SPL v2

SPL

SPL Set ID 777d2ac7-e3cc-4513-8b6f-b90b2ff2c672

Route

oral

Published

Effective Date 2024-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

acetaminophen (650 mg) dextromethorphan (20 mg) guaifenesin (400 mg) phenylephrine (10 mg)

Inactive Ingredients

water acesulfame potassium anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin maltitol propylene glycol sodium benzoate sodium citrate, unspecified form

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

otc monograph drug active Since 2017-07-07

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Medication Information

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.

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
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Directions

do not use more than directed
measure the dose correctly using the enclosed dosing cup
take every 4 hours in dosing cup provided, while symptoms persist
do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

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

Other Information

each 30 mL contains: potassium 30 mg, sodium 14 mg
store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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.

Questions Or Comments?

call 1-855-328-5259

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.

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 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

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, chronic bronchitis or emphysema

Package/label Principal Display Panel

NDC 0067-8132-08

Theraflu ^® Expressmax ^™

SEVERE COLD AND FLU

ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER

DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT

GUAIFENESIN- EXPECTORANT

PHENYLEPHRINE HCl- NASAL DECONGESTANT

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

ALCOHOL FREE

BERRY FLAVOR 8.3 FL OZ (245.5 mL)

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
*Maximum Strength per 4 hour dose.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Trademarks are owned or licensed to the GSK group of companies.
© 2016 GSK group of companies or its licensor. All rights reserved.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

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.

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
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Directions

do not use more than directed
measure the dose correctly using the enclosed dosing cup
take every 4 hours in dosing cup provided, while symptoms persist
do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

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

Other Information (Other information)

each 30 mL contains: potassium 30 mg, sodium 14 mg
store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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.

Questions Or Comments? (Questions or Comments?)

call 1-855-328-5259

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.

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 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 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
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, chronic bronchitis or emphysema

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 0067-8132-08

Theraflu ^® Expressmax ^™

SEVERE COLD AND FLU

ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER

DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT

GUAIFENESIN- EXPECTORANT

PHENYLEPHRINE HCl- NASAL DECONGESTANT

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

ALCOHOL FREE

BERRY FLAVOR 8.3 FL OZ (245.5 mL)

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
*Maximum Strength per 4 hour dose.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Trademarks are owned or licensed to the GSK group of companies.

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

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Raw Label Data

All Sections (JSON)

{"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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "Purposes": "Pain reliever/fever reducer Cough suppressant Expectorant 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 take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL 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 : potassium 30 mg, sodium 14 mg store at controlled room temperature 20-25°C (68-77°F)", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate", "Questions or Comments?": "call 1-855-328-5259", "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.", "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 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg", "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, chronic bronchitis or emphysema", "Package/Label Principal Display Panel": "NDC 0067-8132-08 Theraflu ® Expressmax ™ SEVERE COLD AND FLU ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT GUAIFENESIN- EXPECTORANT PHENYLEPHRINE HCl- NASAL DECONGESTANT BODY ACHE FEVER CHEST CONGESTION NASAL CONGESTION HEADACHE COUGH SORE THROAT PAIN ALCOHOL FREE BERRY FLAVOR 8.3 FL OZ (245.5 mL) PARENTS : Learn about teen medicine abuse www.StopMedicineAbuse.org *Maximum Strength per 4 hour dose. Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 Trademarks are owned or licensed to the GSK group of companies. © 2016 GSK group of companies or its licensor. All rights reserved.", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.884009 · Updated: 2026-03-14T23:02:37.591705