Pain and Fever

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the following guidelines:

For patients weighing less than 24 pounds or under 2 years of age, consultation with a physician is required prior to administration. For patients weighing between 24 to 35 pounds or aged 2 to 3 years, the recommended dose is 1 tablet. For those weighing 36 to 47 pounds or aged 4 to 5 years, the recommended dose is 1 ½ tablets. Patients weighing 48 to 59 pounds or aged 6 to 8 years should receive 2 tablets. For patients weighing 60 to 71 pounds or aged 9 to 10 years, the recommended dose is 2 ½ tablets. Finally, for patients weighing 72 to 95 pounds or aged 11 years, the recommended dose is 3 tablets.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period.

Healthcare professionals should ensure that patients do not receive more than the directed dosage and should consult a physician for any uncertainties regarding dosing.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. The combination may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the acetaminophen content of a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in children who take this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they use it concurrently with other medications containing acetaminophen.

Acetaminophen may also lead to severe skin reactions, which can 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare providers should be consulted prior to use if the child has a history of liver disease. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is necessary for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of the product and consultation with a healthcare provider is recommended if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, presence of redness or swelling, or the emergence of any new symptoms.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients with liver disease should consult a doctor before use.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to stop use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients should discontinue use and consult a healthcare professional if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if any new symptoms appear.

Additionally, it is important for patients to inform their healthcare provider if they are taking the blood-thinning medication warfarin, as this may require special consideration.

In the event of an overdose, immediate medical help should be sought, or a Poison Control Center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Acetaminophen has been identified to potentially increase the risk of bleeding when co-administered with warfarin, an anticoagulant. It is recommended that healthcare professionals closely monitor International Normalized Ratio (INR) levels in patients receiving this combination to ensure safe and effective management of anticoagulation therapy.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not be given this medication without consulting a doctor. For children aged 2 to 11 years, dosing is based on weight as follows: for those weighing 24-35 lbs (2-3 years), 1 tablet is recommended; for 36-47 lbs (4-5 years), 1 1/2 tablets; for 48-59 lbs (6-8 years), 2 tablets; for 60-71 lbs (9-10 years), 2 1/2 tablets; and for 72-95 lbs (11 years), 3 tablets.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Doses may be repeated every 4 hours as needed, but no more than 5 doses should be administered in a 24-hour period.

Warnings include a risk of severe liver damage if more than 5 doses are taken in 24 hours or if used concurrently with other acetaminophen-containing products. There is also an allergy alert for potential severe skin reactions, which may manifest as skin reddening, blisters, or rash; in such cases, use should be discontinued, and medical assistance sought immediately. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Consultation with a doctor is advised if the child has liver disease or is taking the blood-thinning medication warfarin. Parents should stop use and seek medical advice if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, redness or swelling occurs, or any new symptoms appear.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are thoroughly evaluated.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

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 the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. Early recognition and treatment can significantly impact patient outcomes. Therefore, it is essential to ensure that patients and caregivers are informed about the importance of seeking help promptly in the case of suspected overdose.

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 in the event of an overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in any other medications they are taking, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than five days. Similarly, patients should be advised to stop using the medication and seek medical advice if their fever worsens or lasts longer than three days. Additionally, patients should be informed to stop use and consult a doctor if they notice any redness or swelling, or if any new symptoms develop.

It is important for healthcare providers to remind patients to consult a doctor before using this medication if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Care should be taken to avoid high humidity conditions during storage. For tracking purposes, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing, as whole tablets should not be ingested. Dosing can be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to obtain prompt medical attention for both adults and children, even if no symptoms are immediately apparent.

Drug Information (PDF)

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

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