Viro Flu Pm Relief

Description

Viro-Flu PM is available in a dosage form of softgels, with each package containing 10 softgels. The product is identified by the National Drug Code (NDC) 69729-057-10.

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, fever, as well as runny nose and sneezing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should take the medication only as directed. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such treatment. The interaction between this product and MAOIs may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to seek medical attention promptly if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Prior to use, patients should consult a healthcare provider if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, a history of breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland.

In cases of overdose, immediate medical help should be sought, or the Poison Control Center should be contacted without delay. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and consult a healthcare provider if any of the following occur: pain or cough worsens or persists beyond 7 days; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe skin reactions have been reported in patients using acetaminophen, with symptoms including skin reddening, blisters, and rash. If any of these reactions occur, patients are advised to discontinue use immediately and seek medical assistance.

Acetaminophen carries a significant risk of severe liver damage, particularly if patients exceed four doses within a 24-hour period, which is the maximum recommended daily amount. The risk is further heightened when acetaminophen is taken in conjunction with other medications containing the same active ingredient or when patients consume three or more alcoholic drinks daily while using this product.

During treatment, patients may experience excitability, particularly in children, as well as marked drowsiness. It is recommended that patients avoid alcoholic beverages and exercise caution when driving or operating machinery, as the use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a healthcare professional if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have a history of liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should consult a doctor prior to use.

In the event of an overdose, it is critical for patients to seek immediate medical help or contact a Poison Control Center, 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 this product with any other drug 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 product is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription includes an MAOI should consult a healthcare professional prior to using this product.

Caution is advised when this product is used concurrently with alcohol, sedatives, or tranquilizers, as these substances may potentiate drowsiness. Monitoring for increased sedation is recommended, and dosage adjustments may be necessary based on the clinical response and tolerance of the patient.

Packaging & NDC

Below are the non-prescription pack sizes of Viro Flu Pm Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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 medication is not recommended for children under 4 years of age.

Caution is advised as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness has been reported, which may impact the safety and efficacy of the treatment in this population.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the treatment.

Marked drowsiness is a potential side effect, and geriatric patients should exercise caution when driving or operating machinery due to this risk. Additionally, the concurrent use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, necessitating careful monitoring of these combinations in elderly individuals.

In the event of an overdose, prompt medical attention is critical for adults, including those in the geriatric population, to mitigate potential adverse effects.

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 safe use during pregnancy and lactation.

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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the maximum recommended dosage of four doses within a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of liver injury.

Patients are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 instances where no signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, vigilance and timely action are essential in managing potential overdose situations effectively.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed 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.

It is crucial 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 clarification from their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days. Additionally, they should stop using the product and seek medical advice if their fever worsens or lasts more than three days, if they experience redness or swelling, or if new symptoms arise. Patients should also be made aware that if their cough returns or occurs with a rash or headache that lasts, they should seek medical attention, as these may indicate a serious condition.

When using this product, patients should be informed that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. They should be cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients should exercise caution when driving a motor vehicle or operating machinery.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough accompanied by excessive phlegm, or any breathing problems, including chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being two softgels taken with water every six hours. For children aged 4 to under 12 years, it is advised to consult a doctor regarding appropriate use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)