Childrens Pain and Fever

Description

+TopCare® children's Pain & Fever is a chewable tablet formulation containing 160 mg of acetaminophen as the active ingredient. This product is indicated for the relief of pain and reduction of fever in children aged 2 to 11 years. Each bottle contains 24 chewable tablets flavored with grape. The product is tamper evident, and users are advised not to use it if the imprinted safety seal under the cap is broken or missing. The National Drug Code (NDC) for this product is 36800-449-08. It is formulated to be free from ibuprofen and aspirin, and it is comparable to the active ingredient found in Children's Tylenol® Chewables.

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:

• The recommended dosing intervals are every 4 hours as needed while symptoms persist. However, the total number of doses should not exceed 5 doses within a 24-hour period.

• Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consult a physician for guidance.

• For patients weighing 24-35 lb or aged 2-3 years, administer 1 chewable tablet.

• For patients weighing 36-47 lb or aged 4-5 years, administer 1 ½ chewable tablets.

• For patients weighing 48-59 lb or aged 6-8 years, administer 2 chewable tablets.

• For patients weighing 60-71 lb or aged 9-10 years, administer 2 ½ chewable tablets.

• For patients weighing 72-95 lb or aged 11 years, administer 3 chewable tablets.

It is crucial not to exceed the recommended dosage and to consult a healthcare professional if there are any uncertainties regarding the appropriate dose.

Contraindications

The use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This precaution is necessary to avoid the risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, 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 patients that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions 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.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

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

In cases of suspected overdose, immediate medical attention is essential. Patients and caregivers should be advised to contact a Poison Control Center or seek medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it 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.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if any new symptoms arise, or if there is evidence of redness or swelling.

It is recommended that patients consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may arise from unintentional duplication of therapy. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

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 be treated with this medication, with specific dosing recommendations based on weight and age. For children under 24 lb and under 2 years of age, consultation with a doctor is advised prior to use. The following dosing chart applies for children aged 2 to 11 years:

• 24-35 lb (2-3 years): 1 tablet

• 36-47 lb (4-5 years): 1 1/2 tablets

• 48-59 lb (6-8 years): 2 tablets

• 60-71 lb (9-10 years): 2 1/2 tablets

• 72-95 lb (11 years): 3 tablets

It is important not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless directed by a healthcare professional. Prior to administration, healthcare providers should be consulted if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin.

As with all medications, this product should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

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 carefully considered.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to 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 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 should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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, emphasizing that prompt medical attention is critical for both adults and children, even if no signs or symptoms are 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 pain worsens or persists for more than 5 days. Similarly, patients should be advised to stop use and seek medical advice if fever intensifies or lasts longer than 3 days, if any new symptoms develop, or if there is any redness or swelling.

Additionally, it is important for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Patients should also 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

Patients should be advised that the medication is administered orally, with tablets needing to be chewed or crushed completely before swallowing. Dosing can be repeated every 4 hours as long as symptoms persist, but should not exceed 5 doses within a 24-hour period. Additionally, the medication should not be used for more than 5 consecutive days unless directed by a healthcare professional.

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 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)