Childrens Tylenol

Description

Children's TYLENOL® is a chewable formulation containing acetaminophen as the active ingredient, designed for the relief of pain and reduction of fever in children aged 2 to 11 years. Each tablet contains 160 mg of acetaminophen and is free from ibuprofen and aspirin. The product is presented in a bubble gum flavor and is packaged in a bottle containing 24 chewable tablets. It is recommended that the tablets be chewed or crushed completely before swallowing. The National Drug Code (NDC) for this product is 50580-521-24.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. 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 to ensure safety and efficacy. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight and age.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing should be repeated every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period. It is crucial not to exceed the recommended dosage.

Dosage Chart:

• For patients weighing under 24 lb (under 2 years of age): Consult a doctor for appropriate dosing.

• For patients weighing 24-35 lb (2-3 years of age): Administer 1 tablet.

• For patients weighing 36-47 lb (4-5 years of age): Administer 1½ tablets.

• For patients weighing 48-59 lb (6-8 years of age): Administer 2 tablets.

• For patients weighing 60-71 lb (9-10 years of age): Administer 2½ tablets.

• For patients weighing 72-95 lb (11 years of age): Administer 3 tablets.

It is essential to adhere to these guidelines to avoid the risk of overdose and ensure the safety of the patient.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another 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 within the formulation.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

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

Sore Throat Warning In cases where a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as timely intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Monitoring and Follow-Up Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: worsening pain lasting more than 5 days, fever that worsens or persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling. 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 this 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.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in other medications should consult a doctor or pharmacist. Furthermore, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Before using this product, patients with liver disease should seek medical advice. Additionally, those taking the blood-thinning medication warfarin are encouraged to consult a doctor or pharmacist prior to use.

Patients must adhere to the recommended dosage and should not exceed it. They should discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients require careful consideration regarding dosing and safety. For children under 2 years of age weighing less than 24 lb, it is advised to consult a doctor before administration. For those aged 2 to 3 years and weighing between 24-35 lb, the recommended dose is 1 tablet. Children aged 4 to 5 years, weighing 36-47 lb, should receive 1½ tablets. For children aged 6 to 8 years, weighing 48-59 lb, the dose increases to 2 tablets. Patients aged 9 to 10 years, weighing 60-71 lb, may take 2½ tablets, while those who are 11 years old and weigh between 72-95 lb can be given 3 tablets.

It is crucial to adhere strictly to the recommended dosages to avoid the risk of overdose. Parents and caregivers should keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is essential, as prompt attention is critical for both children and adults, even if no symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor this population closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased monitoring.

Pregnancy

The prescribing information for Children's Tylenol (acetaminophen) does not provide specific data regarding its use during pregnancy. As such, 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 specific information, healthcare providers are encouraged to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy and its potential effects on fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of Children's Tylenol (acetaminophen) in nursing mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided information.

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 essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation and ongoing monitoring may be necessary to ensure safety and efficacy in this population.

Overdosage

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 for both adults and children, even in the absence of observable 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 comprehensive 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product 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 packaging that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) and must be kept away from high humidity. Additionally, it is essential to protect the product from light exposure to maintain its integrity.

Healthcare professionals should ensure that the foil inner seal imprinted with "TYLENOL" is intact before use. If the seal is broken or missing, the product should not be used.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)