Childrens Pain and Fever

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

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 and age. It is essential to shake the product well before use. The enclosed dosing cup, specifically designed for this product, must be utilized; no other dosing devices should be employed.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

The following dosage chart provides guidance based on weight and age:

• For patients weighing less than 24 lb and under 2 years of age, the dose is to be determined by a doctor.

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

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

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

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

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

Dosing should be adjusted as necessary and always in accordance with a healthcare provider's recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Additionally, it is essential to adhere to the recommended dosage, as exceeding this may lead to overdose, which poses significant health risks.

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 without delay.

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

Healthcare professionals should inquire about the presence of liver disease in pediatric patients prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant medication, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no symptoms are apparent, as rapid intervention can be critical.

Patients should be instructed to discontinue use and consult a healthcare provider if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These symptoms may indicate a serious condition requiring further evaluation.

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 is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical, even if no signs or symptoms are present. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance promptly.

Patients should also be vigilant for signs of serious conditions. They are advised to stop use and consult a doctor if new symptoms arise, if redness or swelling is observed, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These symptoms may indicate a serious underlying condition.

Furthermore, a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants immediate medical consultation.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may elevate the risk of bleeding complications.

Currently, there are no additional drug interactions or laboratory test interactions reported for this medication. Regular monitoring and dosage adjustments may be necessary based on clinical judgment and patient response, particularly in the context of concurrent anticoagulant therapy.

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 may receive this medication according to the following dosing guidelines based on weight and age. For children under 24 lb (under 2 years), consultation with a doctor is advised before use. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 5 mL; for 36-47 lb (ages 4-5 years), 7.5 mL; for 48-59 lb (ages 6-8 years), 10 mL; for 60-71 lb (ages 9-10 years), 12.5 mL; and for 72-95 lb (age 11 years), 15 mL.

It is important to note that no more than 5 doses should be administered within a 24-hour period, and treatment should not exceed 5 days unless directed by a healthcare professional. Prior to use, consultation with a doctor is recommended if the pediatric patient has liver disease or is taking the anticoagulant warfarin.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is advised.

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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on nursing infants are not well studied; therefore, caution is advised.

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 use, particularly if they have a history of liver disease. It is crucial to adhere to the recommended dosage, as exceeding this may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily amount. Additionally, caution is advised when considering the use of acetaminophen in conjunction with other medications that also contain acetaminophen, as this combination may further increase the risk of severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Prompt medical intervention is crucial, even if the individual does not exhibit any noticeable signs or symptoms of overdose. Healthcare professionals should be aware that early recognition and management of an overdose can be vital in preventing severe 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

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult with a doctor or pharmacist.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Additionally, patients should be instructed to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

Healthcare providers should remind patients to adhere strictly to the recommended dosage to avoid the risk of overdose. Furthermore, patients should be advised to consult a doctor before using this product if their child has liver disease or is currently taking the anticoagulant medication warfarin, as these factors may influence the safety and efficacy of the treatment.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which can be referenced for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. For traceability, the lot number and expiration date can be found on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not exceeding 5 doses within a 24-hour period. Continuous use should not exceed 5 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Additionally, patients should be advised to discontinue use and seek medical attention if new symptoms arise, if there is redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

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)