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Theraflu Expressmax

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Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
  • Phenylephrine Hydrochloride 10 mg/30 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
February 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
  • Phenylephrine Hydrochloride 10 mg/30 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
February 12, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
M012
NDC root
0067-8127
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

THERAFLU ExpressMax Daytime Severe Cold & Cough is a maximum strength medication designed to temporarily relieve various symptoms associated with the common cold. It contains key ingredients such as acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), and phenylephrine HCl (a nasal decongestant). This combination helps alleviate minor aches and pains, sore throat, headaches, nasal and sinus congestion, and cough due to throat and bronchial irritation, while also reducing fever.

This alcohol-free product comes in a pleasant berry flavor and is intended for daytime use, providing relief from cold symptoms so you can feel more comfortable throughout your day.

Uses

This medication is designed to help you feel better when you're dealing with a cold. It can temporarily relieve minor aches and pains, soothe a sore throat, ease headaches, and reduce nasal and sinus congestion. If you're experiencing a cough due to minor throat and bronchial irritation, this medication can also help with that.

In addition to alleviating these symptoms, it can temporarily lower a fever, making you more comfortable as you recover. Remember, while this medication can help with these cold symptoms, it’s always a good idea to consult with a healthcare professional if you have any concerns.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should only take the amount directed and use the dosing cup provided to measure your dose accurately. For adults and children aged 12 years and older, the recommended dose is 30 mL, which you can take every 4 hours as needed while your symptoms persist.

However, be cautious not to exceed 5 doses, which totals 150 mL, within a 24-hour period unless your doctor advises otherwise. If you have children under 12 years of age, this medication is not suitable for them, so please avoid using it for that age group. Always consult with your healthcare provider if you have any questions or concerns about your dosage.

What to Avoid

You should avoid using this medication if you are a child under 12 years of age or if you are allergic to acetaminophen. It's also important not to take this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult with a doctor or pharmacist.

Additionally, do not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for certain mental health conditions or Parkinson’s disease, or if you have stopped taking an MAOI within the last two weeks. If you have any questions about your medications, don't hesitate to ask a healthcare professional for guidance.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as redness, blisters, or rashes. If you experience any skin issues, stop using the product and seek medical help immediately.

You should stop using this product and consult a doctor if you experience nervousness, dizziness, sleeplessness, or if your fever worsens or lasts more than three days. Additionally, if you notice redness or swelling, new symptoms arise, or if pain, cough, or nasal congestion worsens or lasts more than seven days, it's important to seek medical advice. Always consult a doctor before using this product if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or other specific health concerns. In case of overdose, seek medical help or contact a Poison Control Center right away, as prompt attention is crucial.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as redness, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a chronic cough. If you are taking the blood thinner warfarin, consult your doctor or pharmacist before use. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away, even if you don't notice any symptoms.

You should stop taking this product and call your doctor if you experience nervousness, dizziness, or sleeplessness; if your fever worsens or lasts more than three days; if you notice redness or swelling; if new symptoms develop; or if your pain, cough, or nasal congestion worsens or lasts more than seven days. Additionally, if your cough returns with a rash or headache that lasts, these could be signs of a serious condition that requires medical attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Always err on the side of caution and get help right away if you think an overdose has occurred. Your quick action can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to know that this medication should not be given to children under 12 years of age. For those who are 12 years and older, the recommended dose is 30 mL. Always consult with your healthcare provider before administering any medication to ensure it is safe and appropriate for your child's specific needs.

Geriatric Use

While there is no specific information about the use of THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH in older adults, it’s important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize your safety and well-being when considering new treatments.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver disease, it's important to consult your doctor before using this product. There is a significant risk of liver damage, especially since this product contains acetaminophen. You should be aware that taking more than 4,000 mg of acetaminophen in a 24-hour period, using other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can greatly increase the risk of severe liver damage.

To ensure your safety, always follow your healthcare provider's advice regarding dosage and monitor your liver health closely. Taking these precautions can help protect your liver while using this medication.

Drug Interactions

It's important to be cautious about combining medications. You should not take this medication with any other products that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently using a monoamine oxidase inhibitor (MAOI)—a type of medication often prescribed for depression or certain emotional conditions—or have stopped taking one within the last two weeks, you should avoid this medication. Also, if you are on the blood thinner warfarin, it's crucial to discuss this with your healthcare provider.

Always talk to your healthcare provider about any medications you are taking, including over-the-counter drugs and supplements. This helps ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is THERAFLU ExpressMax Daytime Severe Cold & Cough?

THERAFLU ExpressMax Daytime Severe Cold & Cough is a maximum strength, alcohol-free medication designed to temporarily relieve symptoms of a cold, including aches, sore throat, headache, nasal congestion, and cough.

What are the key ingredients in THERAFLU ExpressMax?

The key ingredients include acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), and phenylephrine HCl (a nasal decongestant).

How should I take THERAFLU ExpressMax?

You should take 30 mL every 4 hours while symptoms persist, using the enclosed dosing cup. Do not exceed 5 doses (150 mL) in 24 hours unless directed by a doctor.

Who should not use THERAFLU ExpressMax?

Do not use this product in children under 12 years of age, if you are allergic to acetaminophen, or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What are the warnings associated with THERAFLU ExpressMax?

Warnings include the risk of severe liver damage if you exceed 4,000 mg of acetaminophen in 24 hours, use with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

Can I use THERAFLU ExpressMax if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using THERAFLU ExpressMax.

What should I do if I experience side effects?

Stop using the product and call your doctor if you experience nervousness, dizziness, sleeplessness, or if your symptoms worsen or new symptoms occur.

Packaging Info

Below are the non-prescription pack sizes of Theraflu Expressmax (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraflu Expressmax.
Details

Drug Information (PDF)

This file contains official product information for Theraflu Expressmax, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Theraflu ExpressMax Daytime Severe Cold & Cough is a liquid formulation designed to relieve multiple symptoms associated with colds and flu. Each 8.3 fl oz (245.5 mL) bottle contains a combination of active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. This product is alcohol-free and features a berry flavor. It is indicated for the relief of cough, nasal congestion, sore throat pain, fever, headache, and body aches. The maximum strength is provided per 4-hour dose. The product is distributed by GSK Consumer Healthcare, Warren, NJ 07059. The NDC for this product is 0067-8127-08. Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. Use is contraindicated if the neckband printed with “Sealed for Safety” is torn or missing.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, minor sore throat pain, headache, nasal and sinus congestion, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be administered according to the following guidelines. It is imperative that the dosage does not exceed the recommended limits. Healthcare professionals should instruct patients to measure the dose accurately using the enclosed dosing cup.

For adults and children aged 12 years and older, the recommended dose is 30 mL, to be taken every 4 hours as needed while symptoms persist. Patients should not exceed 5 doses (150 mL) within a 24-hour period unless specifically directed by a healthcare provider.

It is important to note that this medication is not indicated for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

  • In children under 12 years of age.

  • In individuals with a known allergy to acetaminophen.

  • In conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

  • In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen in a 24-hour period, uses this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm or is chronic (e.g., due to smoking, asthma, or emphysema). Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

When to Stop Taking the Product Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if pain, cough, or nasal congestion worsens or lasts more than seven days. Additionally, if a cough recurs or is accompanied by a rash or headache that persists, these may indicate a serious condition requiring further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a need for prompt medical consultation.

It is recommended that patients stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if pain, cough, or nasal congestion worsens or persists for more than seven days. A return of cough accompanied by rash or headache that lasts may also be indicative of a serious condition requiring medical evaluation.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a chronic cough associated with smoking, asthma, or emphysema should also seek medical advice prior to use. Furthermore, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. This interaction may lead to serious adverse effects, including hypertensive crises.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Monitoring of coagulation parameters is recommended to ensure that the anticoagulant effect is maintained within the desired therapeutic range, as this combination may alter the effectiveness of warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Theraflu Expressmax (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraflu Expressmax.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. For those aged 12 years and older, the recommended dosage is 30 mL. Caution is advised when considering treatment in this age group, and healthcare professionals should ensure that the benefits outweigh any potential risks.

Geriatric Use

There is no specific information regarding the use of THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when administering this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for potential adverse effects may be warranted, given the general considerations for medication use in older adults.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage. Patients are advised to avoid exceeding a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic beverages daily while using this product may further increase the risk of liver damage. Careful monitoring of liver function is recommended for patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: severe skin reactions, which include symptoms such as skin reddening, blisters, and rash.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage of the medication. Patients must be informed that exceeding the recommended dosage can lead to serious health risks.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly impact the outcome in cases of overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Theraflu Expressmax, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Theraflu Expressmax, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.