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 and should not be administered to individuals under 3 years of age unless directed by a physician. For children aged 3 to 6 years, 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 from the suppository. The suppository must be carefully inserted well up into the rectum to ensure proper delivery of the medication. It is imperative to adhere strictly to the recommended dosing guidelines and not exceed the directed amount.

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 prohibited. 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 the maximum daily dosage is exceeded. Specifically, liver damage may occur if a child takes more than five doses within a 24-hour period or if acetaminophen is used concurrently with other medications containing acetaminophen.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions This product should not be used by individuals with a known allergy to acetaminophen. Additionally, it is contraindicated to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional, such as a doctor or pharmacist, is advised.

Healthcare professionals should be consulted prior to use if the child has a history of liver disease or is currently taking the anticoagulant warfarin.

Emergency Medical Help Instructions In cases of ingestion or suspected overdose, immediate medical attention is essential. Contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical, particularly in cases of overdose in both adults and children, even if no symptoms are apparent.

Stop Taking and Call Your Doctor Instructions Discontinue use and consult a healthcare provider if any of the following occur: fever persists for more than three days (72 hours) or recurs; pain lasts longer than five days or worsens; new symptoms develop; or if redness or swelling is observed in the affected area. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients if more than five doses of the medication are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases when the medication is used concurrently with other drugs containing acetaminophen.

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

The medication is contraindicated in patients with a known allergy to acetaminophen and should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients are advised to consult a healthcare professional.

Before using this medication, it is recommended that patients consult a doctor if the child has liver disease or is taking the anticoagulant warfarin.

Patients should discontinue use and seek medical advice if fever persists for more than three days (72 hours) or recurs, if pain lasts more than five days or worsens, if new symptoms develop, or if redness or swelling is observed in the painful area. These symptoms may indicate a serious underlying condition.

Drug Interactions

Acetaminophen has been shown to enhance the anticoagulant effects of warfarin, which may result in an elevated 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 therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or laboratory test interactions 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 3 years of age should not use this medication unless directed by a healthcare professional. For children aged 3 to 6 years, the recommended dosing is 1 suppository every 4 to 6 hours, with a maximum of 5 doses in a 24-hour period.

Caution is advised regarding liver health; severe liver damage may occur if a child exceeds 5 doses in 24 hours, particularly when combined with other medications containing acetaminophen. Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if a child's fever persists for more than 3 days (72 hours), if pain lasts longer than 5 days or worsens, if new symptoms develop, or if there is redness or swelling in the area of pain.

Geriatric Use

Elderly patients may not have specific directions or warnings for adult use associated with this product. Therefore, healthcare providers should exercise caution when considering its use in this population. It is essential to evaluate the individual health status and potential risks in geriatric patients, as they may have different pharmacokinetic and pharmacodynamic responses compared to younger adults. Monitoring for adverse effects and therapeutic efficacy is recommended to ensure patient safety.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. Potential risks to the fetus have not been fully evaluated; therefore, caution is advised when considering the use of acetaminophen in this population.

No specific dosage modifications for pregnant individuals are provided; healthcare professionals should be consulted for guidance on appropriate use. The decision to use acetaminophen during pregnancy should be based on a careful assessment of the benefits versus risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 use, particularly if there is a history of liver disease. It is important to note that severe liver damage may occur if the maximum daily dosage of 5 doses within a 24-hour period is exceeded, or if the patient is concurrently using other medications that contain acetaminophen. Monitoring of liver function is advised in patients with compromised liver function to prevent potential adverse effects associated with acetaminophen use.

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 apparent.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The absence of observable symptoms does not preclude the possibility of serious complications; therefore, thorough evaluation and monitoring are essential.

In summary, swift action is necessary to ensure the safety and well-being of individuals who may have ingested an excessive amount of the medication.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

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

Additionally, it is emphasized that acetaminophen should be kept out of reach of children. In cases of accidental ingestion or overdose, prompt medical attention is crucial. This is particularly important for adults and children, even if no signs or symptoms are initially apparent.

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 no signs or symptoms are immediately apparent. This proactive approach can significantly mitigate potential risks associated with 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. Clinicians should advise patients to keep the medication out of reach of children. In the event of accidental ingestion or overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential, particularly for 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)