Fever Reducing

Description

Acetaminophen suppositories are formulated as a pain reliever and fever reducer specifically for children aged 3 to 6 years. Each suppository contains 120 mg of acetaminophen, and the product is supplied in a package containing 12 rectal suppositories, each delivering the specified dosage.

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. For pediatric patients under 3 years of age, the product should not be used unless directed by a physician.

For children aged 3 to 6 years, the recommended dosage is 1 suppository administered every 4 to 6 hours, with a maximum of 5 doses within a 24-hour period.

Prior to administration, the wrapper should be removed. The suppository should be carefully inserted well up into the rectum to ensure proper delivery of the medication. It is imperative to adhere strictly to the dosing guidelines and not exceed the recommended dosage.

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

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Before administering this product, it is essential to consult a physician if the child has a history of liver disease or is currently taking the anticoagulant warfarin. These conditions may necessitate additional monitoring or alternative therapeutic strategies.

In cases of accidental ingestion or suspected overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if the child experiences a fever lasting more than 72 hours, persistent or worsening pain beyond five days, the emergence of new symptoms, or any redness or swelling 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 more than 5 doses of the product are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage increases if this product is used concurrently with other medications containing acetaminophen.

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

This product is contraindicated in individuals with a known allergy to acetaminophen and should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications are advised to consult a healthcare professional.

Before using this product, it is recommended that patients consult a doctor if their 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 3 days (72 hours), if pain lasts longer than 5 days or worsens, if new symptoms arise, or if there is redness or swelling in the area of pain, as these may indicate a serious condition.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

In pediatric patients, particular caution is warranted when this medication is used concurrently with warfarin, a blood-thinning agent. Monitoring of coagulation parameters may be necessary to ensure therapeutic efficacy and safety, as the interaction could potentially alter the anticoagulant effect of warfarin.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Fever Reducing (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 dosage is 1 suppository every 4 to 6 hours, with a maximum of 5 doses in a 24-hour period.

Healthcare providers should be aware of the potential for severe liver damage if the maximum daily dosage is exceeded. It is advised to consult a physician before use if the child has liver disease or is concurrently taking the anticoagulant warfarin.

In the event of accidental ingestion or overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial in cases of overdose, regardless of the presence of symptoms.

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 prescribing this medication to geriatric patients. It is essential to consider the unique pharmacokinetic and pharmacodynamic changes that occur with aging, which may affect drug metabolism and response.

Due to the absence of established guidelines for this population, careful monitoring for efficacy and safety is recommended. Providers should assess the individual health status of elderly patients and consider potential risks versus benefits when determining the appropriateness of this product for their treatment.

Pregnancy

Pregnant patients should not use this medication unless directed by a healthcare professional. The potential risks associated with the use of this medication during pregnancy have not been fully established. Therefore, it is essential for women of childbearing potential to consult their healthcare provider to evaluate the benefits and risks before initiating treatment. Caution is advised to ensure the safety of both the mother and the developing fetus.

Lactation

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

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy 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. The national Poison Control Center can be reached at 1-800-222-1222.

It is important to note that prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Vigilance in monitoring for potential symptoms is necessary, as the absence of immediate effects does not preclude the possibility of serious complications.

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 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

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the medication is swallowed or in the event of an overdose. It is essential to emphasize that prompt medical attention is critical in cases of overdose, particularly for adults and children, even if no signs or symptoms are initially apparent. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in a tamper-evident configuration, with each suppository individually wrapped. It is essential to inspect the packaging prior to use; do not utilize any suppository if the printed wrapper is opened or damaged.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F) or in a cool place to ensure its integrity and effectiveness.

Additional Clinical Information

For rectal administration, the recommended dosage is one suppository every 4 to 6 hours, with a maximum of five doses within a 24-hour period. Clinicians should advise patients to discontinue use and seek immediate medical assistance if a skin reaction occurs. It is essential to keep the product out of reach of children. In the event of accidental ingestion or overdose, patients should promptly contact a medical professional or Poison Control Center at 1-800-222-1222, as swift medical attention is crucial, particularly for adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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