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

The medication should be administered according to the following guidelines. It is imperative that the dosage does not exceed the recommended limits.

For patients under 6 years of age, the use of this medication is not advised.

For children aged 6 to 12 years, the recommended dosage is 1 suppository every 4 to 6 hours, with a maximum of 5 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 suppositories every 4 to 6 hours, with a maximum of 6 doses in 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 the following situations:

• Children under 6 years of age.

• Patients with a known allergy to acetaminophen.

• Concurrent use 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.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to guidelines. Severe liver damage may occur under the following circumstances: if a child aged 6 to 12 years takes more than 5 doses within a 24-hour period; if an adult or child aged 12 years and older exceeds 6 doses in 24 hours, which is the maximum daily amount; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Healthcare professionals should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms 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.

General precautions should be taken prior to use. Patients should be advised to consult a physician if they have liver disease or are taking the anticoagulant warfarin, as these conditions may increase the risk of adverse effects.

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

Patients should also be advised to discontinue use and consult a healthcare provider if any of the following occur: fever persists for more than 3 days (72 hours) or recurs; pain worsens or lasts longer than 10 days; new symptoms develop; or if redness or swelling is observed in the affected area. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients if specific dosing guidelines are not followed. In children aged 6 to 12 years, taking more than 5 doses in a 24-hour period can lead to significant liver injury. For adults and children aged 12 years and older, exceeding 6 doses in 24 hours, which is the maximum daily amount, poses a similar risk. The potential for liver damage is further increased when this product is taken in conjunction with other medications containing acetaminophen or when an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions associated with acetaminophen. 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.

This product is contraindicated in children under 6 years of age and in individuals with a known allergy to acetaminophen. It should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a healthcare professional.

Before using this product, patients should consult a doctor if they have liver disease or are taking the anticoagulant warfarin.

Patients are advised to discontinue use and seek medical advice if fever persists for more than 3 days (72 hours), if pain worsens or lasts longer than 10 days, if new symptoms develop, or if redness or swelling occurs in the affected area, as these may indicate a serious underlying condition.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 years of age should not use this medication. For children aged 6 to 12 years, the recommended dosage is 1 suppository every 4 to 6 hours, with a maximum of 5 doses in a 24-hour period. Caution is advised, as severe liver damage may occur if a child in this age group exceeds the maximum dosage of 5 doses within 24 hours.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual patient's health status and any potential risks associated with their age. Monitoring for efficacy and safety is advised, as is the consideration of any comorbidities that may affect treatment outcomes in elderly individuals.

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 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 individuals 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 using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on this medication.

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 proactive approach to management.

Upon recognition of an overdose, healthcare providers should ensure that appropriate measures are taken to assess the patient's condition and initiate necessary treatment protocols. This may include monitoring vital signs, providing supportive care, and implementing specific interventions based on the substance involved and the clinical presentation.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

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

Patient Counseling

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using this medication. It is important for them to understand the potential risks and benefits associated with its use during these periods.

Healthcare providers should emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion. Patients should be informed about the importance of safeguarding their medications and ensuring that they are stored securely.

In the event of accidental ingestion or overdose, patients must be instructed to seek medical help immediately or contact a Poison Control Center. It is crucial to communicate that prompt medical attention is essential in cases of overdose, particularly for adults and children, even if no signs or symptoms are initially apparent.

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

Patients should be advised on the proper route, method, and frequency of administration for the medication. For children aged 6 to 12 years, the recommended dosage is one suppository every 4 to 6 hours, with a maximum of five doses in a 24-hour period. For adults and children aged 12 years and older, the dosage is two suppositories every 4 to 6 hours, not exceeding six doses in 24 hours.

Clinicians should counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before use. Additionally, it is crucial to keep the medication out of reach of children. In the event of accidental ingestion or overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt medical attention is vital, especially for children, regardless of the presence of symptoms.

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)