Childrens 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, toothache, sore throat, influenza, 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 specific dosing instructions must be followed. Prior to administration, the product should be shaken well. The provided dose cup must be used to ensure accurate measurement.

Dosing should be determined primarily by the patient's weight; however, age may be used as an alternative if weight is not available. The following dosing chart should be referenced:

• For patients weighing under 24 lb or under 2 years of age, consult a doctor for appropriate dosing.

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period. It is imperative to adhere to these guidelines and not exceed the recommended dosage.

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 with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that the maximum daily dosage for children is five doses within a 24-hour period. Caution is warranted if the product is administered concurrently with other medications containing acetaminophen, as this may increase the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should inquire about the presence of liver disease prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms arise, or if there is any redness or swelling.

Side Effects

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

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. It is crucial for patients to adhere to the recommended dosage to mitigate the risk of liver injury.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional without delay.

Patients should stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists beyond three days, if any new symptoms arise, or if there is evidence of redness or swelling.

Before using this product, it is recommended that patients with liver disease consult a healthcare provider. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. Monitoring of INR (International Normalized Ratio) levels may be warranted to ensure therapeutic efficacy and safety, as acetaminophen can potentially alter the anticoagulant effect of warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 11 years are recommended for use of this medication. Dosing varies by weight, with specific guidelines as follows: for children under 24 lb (under 2 years), consultation with a doctor is advised; for those weighing 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), the dose is 7.5 mL; for 48-59 lb (6-8 years), the dose is 10 mL; for 60-71 lb (9-10 years), the dose is 12.5 mL; and for 72-95 lb (11 years), the dose is 15 mL. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Healthcare professionals should be aware of several warnings associated with this medication. There is a risk of severe liver damage if more than 5 doses are taken within 24 hours. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If a pediatric patient experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

It is important to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Parents or caregivers should also be advised to stop use and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if any new symptoms appear, or if redness or swelling is present.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects may be warranted, as elderly patients often have altered pharmacokinetics and may be more susceptible to medication-related complications.

Pregnancy

There is no specific information available regarding the use of acetaminophen during pregnancy. The prescribing information does not indicate any contraindications or risks associated with the use of acetaminophen in pregnant individuals. Additionally, no dosage modifications for pregnant patients are specified. The insert also does not include any special precautions regarding the use of acetaminophen during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on 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. 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 that a healthcare professional be consulted 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 potential need for 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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose situations effectively.

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 rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

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, if a patient's fever worsens or lasts longer than three days, they should stop using the medication and seek medical advice. Patients should also be advised to stop use and contact a doctor if they experience any new symptoms, or if they notice redness or swelling.

For pediatric patients, healthcare providers should recommend that parents or guardians consult a doctor before using this medication if their child has liver disease. Additionally, it is important to advise them to speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to 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. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Drug Information (PDF)

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

View product document (PDF)