Theraflu Expressmax

Description

Theraflu® ExpressMax® Daytime Severe Cold & Cough is a combination medication designed to provide warming relief from symptoms associated with severe cold and cough. Each coated caplet contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. This formulation addresses nasal congestion, sore throat, headache, body ache, cough, and fever. The product is available in a package containing 20 coated caplets, which are sealed in tamper-evident blister packets. It is distributed by GSK Consumer Healthcare, Warren, NJ 07059. Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK group of companies or its licensor. All rights reserved. For more information, visit www.theraflu.com.

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

Adults and children 12 years of age and over are instructed to take 2 caplets orally every 4 hours, as needed, while symptoms persist. It is imperative that they do not exceed a total of 10 caplets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended.

Healthcare professionals should ensure that patients are aware of the importance of adhering to the recommended dosage and administration guidelines to avoid potential adverse effects.

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.

• Concurrently 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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a severe sore throat that persists for more than two days, particularly if accompanied by fever, headache, rash, nausea, or vomiting. Such symptoms warrant prompt medical consultation.

Patients should be advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if fever worsens or lasts longer than three days, or if redness or swelling occurs, medical advice should be sought. New symptoms, or worsening pain, cough, or nasal congestion lasting more than seven days, should also prompt a consultation. A cough that recurs or is accompanied by a rash or headache that persists may indicate a serious condition requiring further evaluation.

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

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 and seek medical assistance immediately.

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 serious condition requiring 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 is present; if new symptoms arise; or if pain, cough, or nasal congestion worsens or lasts more than seven days. A return of cough or the occurrence of cough with rash or headache that persists may also signal a serious condition.

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, patients 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 other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI to avoid potential hypertensive crises.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe and effective use.

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.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There is insufficient safety and efficacy data to support its use in this population. Therefore, healthcare professionals are advised to avoid prescribing this medication to children in this age group.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face particular safety concerns as indicated in the provided information. However, it is strongly advised that geriatric patients consult a healthcare provider prior to use, particularly if they have underlying health conditions. These conditions may include liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulties with urination due to an enlarged prostate gland.

Healthcare providers should remain vigilant in monitoring elderly patients for any potential adverse effects and ensure that appropriate evaluations are conducted to manage any pre-existing health issues effectively.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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. The presence of liver disease may necessitate caution due to the potential for increased risk of adverse effects.

This product contains acetaminophen, which is associated with the risk of severe liver damage. Patients with compromised liver function should be particularly vigilant regarding the maximum dosage of acetaminophen. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and efficacy while using this product.

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 intervention 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 health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage and not exceeding it. Patients should be made aware that taking more than the prescribed amount can lead to serious health risks.

In the event of an overdose, healthcare providers must instruct patients to seek medical help immediately or contact a Poison Control Center. It is crucial to emphasize that prompt medical attention is necessary 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

TheraFlu ExpressMax caplets are supplied in blister packets, with each packet containing a specific number of caplets. The product should be stored at a controlled room temperature of 20°-25°C (68°-77°F). It is essential to keep the carton for reference and not to discard it. Additionally, the caplets should only be used if the individual seal on the blister packet is unbroken, ensuring the integrity and safety of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours as needed, with a maximum of 10 caplets in a 24-hour period unless otherwise directed by a healthcare provider. The medication is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using this medication. Additionally, information regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. There are no further details available regarding laboratory tests or postmarketing experiences.

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)