Feverall

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches, pains, and headaches.

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

Dosage and Administration

This product is not indicated for use in adults. It is essential to adhere strictly to the recommended dosing guidelines and not exceed the directed dosage.

For infants under 6 months of age, the product should not be used unless specifically directed by a healthcare professional.

For infants aged 6 to 11 months, the recommended dosage is one suppository every 6 hours, with a maximum of four doses within a 24-hour period.

For children aged 12 to 36 months, the recommended dosage is one suppository every 4 to 6 hours, with a maximum of five doses within a 24-hour period.

Prior to administration, the wrapper should be removed. The suppository must be carefully inserted well up into the rectum to ensure proper delivery of the medication.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if dosages exceed the recommended limits. For children aged 6 to 11 months, the maximum allowable dosage is 4 doses within a 24-hour period. For children aged 12 to 36 months, the maximum is 5 doses in the same timeframe. Additionally, caution is advised when administering this product alongside other medications that contain acetaminophen, as this may lead to unintentional overdose.

Allergy Alert Acetaminophen may induce severe skin reactions. Healthcare professionals should be vigilant for symptoms such as skin reddening, blisters, or rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions Prior to administration, it is essential to consult a physician if the child has a history of liver disease or is currently taking the anticoagulant medication warfarin. These conditions may necessitate closer monitoring and potential adjustments in treatment.

Emergency Medical Help In the event of accidental ingestion or suspected overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Discontinuation and Consultation Healthcare professionals should advise caregivers to stop use and consult a physician if any of the following occur: fever persists for more than 3 days (72 hours) or recurs, pain lasts beyond 3 days or worsens, new symptoms arise, or if there is redness or swelling in the area of pain. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients if the maximum daily dosage of acetaminophen is exceeded. For children aged 6 to 11 months, this maximum is four doses within 24 hours, while for those aged 12 to 36 months, it is five doses. Additionally, the risk of liver damage increases when acetaminophen is taken concurrently with other medications containing the same active ingredient.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Acetaminophen should not be used in patients with a known allergy to the drug or in conjunction with any other medications 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.

Before administering acetaminophen, it is recommended to consult a healthcare provider if the child has liver disease or is taking the anticoagulant warfarin.

Patients should discontinue use and consult a healthcare provider if fever persists for more than three days (72 hours), if pain lasts longer than three days or worsens, if new symptoms arise, or if redness or swelling occurs in the area of pain, as these may indicate a serious underlying condition.

In cases of accidental ingestion or overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is essential, particularly for children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effect of warfarin, which may lead to an increased risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe and effective management of anticoagulation therapy.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Feverall (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 months of age should not use this medication unless directed by a healthcare professional. For those aged 6 to 11 months, the recommended dosage is 1 suppository every 6 hours, with a maximum of 4 doses in a 24-hour period. For children aged 12 to 36 months, the dosage is 1 suppository every 4 to 6 hours, with a maximum of 5 doses in 24 hours.

Caution is advised due to the risk of severe liver damage; this may occur if a child takes more than 4 doses in 24 hours (ages 6 to 11 months) or more than 5 doses in 24 hours (ages 12 to 36 months). Healthcare professionals should be consulted before use if the child has liver disease or is taking the anticoagulant warfarin.

Parents and caregivers should discontinue use and seek medical advice if the child's fever persists for more than 3 days (72 hours), pain lasts beyond 3 days or worsens, new symptoms develop, or if there is redness or swelling in the affected area.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. Additionally, there are no directions or warnings outlined for adult use, which may limit the ability to assess safety and efficacy in this population.

Healthcare providers should exercise caution when considering this product for geriatric patients, given the absence of data. It is advisable to monitor these patients closely for any adverse effects or unexpected responses, and to consider potential dose adjustments based on individual patient factors, including comorbidities and concurrent medications.

Pregnancy

The safety of this product during pregnancy has not been established. Use is not recommended during pregnancy unless directed by a healthcare provider. There may be potential risks to the fetus; therefore, it is essential for pregnant patients to consult a healthcare professional before use.

Dosage adjustments may be necessary for pregnant individuals, and medical advice should be sought to determine appropriate dosing during pregnancy. It is crucial for women of childbearing potential to discuss the use of this product with their healthcare provider to weigh the benefits against potential risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if there is a history of liver disease. It is essential to assess liver function to determine the appropriateness of treatment and any necessary adjustments in dosage or monitoring requirements. Careful consideration and evaluation by a physician are recommended to ensure the safety and efficacy of the medication in this population.

Overdosage

In the event of an overdose, immediate medical assistance is essential. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay. This is crucial for both adults and children, as prompt intervention can significantly impact outcomes.

It is important to note that symptoms of overdose may not always be immediately apparent. Therefore, even in the absence of noticeable signs or symptoms, medical evaluation is warranted, particularly in pediatric cases. The potential for delayed reactions necessitates a cautious approach, emphasizing the importance of vigilance and proactive management in overdose situations.

Healthcare providers should ensure that patients and their families are aware of the appropriate steps to take in the event of an overdose, reinforcing the critical nature of timely medical intervention.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms may 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 the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center if the medication is swallowed or in the event of an overdose. Quick medical attention is critical, particularly for adults and children, even if there are no noticeable signs or symptoms of overdose.

Storage and Handling

The product is supplied in a configuration that includes an imprinted suppository wrapper. It is essential to ensure that the wrapper remains intact; do not use the product if the wrapper is opened or damaged.

For optimal storage, the product should be maintained at a temperature range of 2° to 27°C (35° to 80°F). Proper handling and storage conditions are crucial to preserve the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is rectal. For patients aged 6 to 11 months, the recommended dosage is one suppository every 6 hours, with a maximum of four doses in a 24-hour period. For those aged 12 to 36 months, the dosage is one suppository every 4 to 6 hours, not exceeding five doses in 24 hours.

Clinicians should advise patients and caregivers to keep the medication out of reach of children. In the event of accidental ingestion or overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is crucial in cases of overdose, particularly for adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)