Viro-Flu Am Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, not to exceed 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations. The use of this medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a current prescription, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients to avoid exceeding four doses within a 24-hour period, as this is the maximum daily amount. Additionally, patients should be cautioned against using this product in conjunction with other medications containing acetaminophen and consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

Before recommending this product, healthcare providers should inquire about the patient's medical history. It is particularly important to consult a physician if the patient has any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with a persistent or chronic cough, such as those with smoking history, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before using this product.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms worsen or persist beyond five days for children or seven days for adults, or if fever worsens or lasts more than three days, medical consultation is warranted. Signs of redness or swelling, the emergence of new symptoms, or a returning cough accompanied by a rash or persistent headache may indicate a serious condition, necessitating further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver damage and severe allergic reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of four doses within 24 hours, take this product in conjunction with other medications containing acetaminophen, 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 stop using the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening conditions that last beyond five days for children or seven days for adults, fever that persists or worsens beyond three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, diabetes, high blood pressure, or urinary issues related to an enlarged prostate should consult a healthcare provider. Additionally, those experiencing a cough with excessive phlegm or a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

An overdose of this product can lead to serious health complications. In the event of an overdose, it is crucial 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

Co-administration of acetaminophen and warfarin may elevate the risk of bleeding due to potential pharmacodynamic interactions. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Viro-Flu Am Relief (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The safety and efficacy of this medication have not been established in children under 4 years of age, and its use is not recommended in this population.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data may necessitate individualized assessment and monitoring based on clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals recognize the potential risks associated with overdosage and act promptly.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of vigilance even in the absence of noticeable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these critical steps to mitigate the risks associated with overdosage.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to seek guidance from a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms worsen or persist beyond five days for children or seven days for adults. If a fever worsens or lasts more than three days, or if there is any redness or swelling, patients should also be directed to stop use and contact a healthcare provider. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. It is essential for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Viro-Flu Am Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)