Childrens Tylenol

Description

Children's TYLENOL® is an oral suspension containing acetaminophen at a concentration of 160 mg per 5 mL. It is formulated as a pain reliever and fever reducer, suitable for children aged 2 to 11 years. The product is alcohol-free, ibuprofen-free, and aspirin-free, and it does not contain parabens. Each bottle contains 4 fl oz (120 mL) of the suspension, which is flavored with grape. The National Drug Code (NDC) for this product is 50580-612-01.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including 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 pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

Dosage Chart:

• For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing 24-35 lb (2-3 years), the dose is 5 mL.

• For children weighing 36-47 lb (4-5 years), the dose is 7.5 mL.

• For children weighing 48-59 lb (6-8 years), the dose is 10 mL.

• For children weighing 60-71 lb (9-10 years), the dose is 12.5 mL.

• For children weighing 72-95 lb (11 years), the dose is 15 mL.

It is imperative to use only the enclosed dosing cup and not any other dosing device to ensure accurate measurement and administration.

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 due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, 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, exceeding the recommended dosage is contraindicated, as it may lead to serious adverse effects.

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, as this may further increase the risk of liver injury.

Allergy Alert Acetaminophen may induce 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, as interactions may occur.

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

Discontinuation and Consultation Caregivers should be instructed to stop use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take the product concurrently with other medications containing acetaminophen. Patients should be aware that acetaminophen can lead to severe skin reactions, 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.

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 promptly. The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients are advised to consult a doctor or pharmacist. Additionally, the product should not be administered to patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should seek medical advice. Furthermore, patients taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use. It is crucial for patients to adhere to the recommended dosage and to stop use and consult a healthcare provider if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In cases of overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. 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 Tylenol (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 lb (under 2 years) should consult a doctor for dosing recommendations. For those weighing 24-35 lb (2-3 years), the recommended dose is 5 mL; for 36-47 lb (4-5 years), it is 7.5 mL; for 48-59 lb (6-8 years), 10 mL; for 60-71 lb (9-10 years), 12.5 mL; and for 72-95 lb (11 years), 15 mL. Doses 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 use in pediatric patients. Severe liver damage may occur if more than 5 doses are administered within 24 hours. There is an allergy alert for acetaminophen, which may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. 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.

It is advised to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical help should be sought, or a Poison Control Center should be contacted, as prompt medical attention is critical for both children and adults, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is indicated for use in children aged 2-11 years, and there are no documented dosage adjustments or safety concerns specifically addressing the geriatric population.

Healthcare providers should exercise caution when prescribing this product to elderly patients, considering the absence of data on its safety and efficacy in this demographic. Monitoring for potential adverse effects is advisable, given the lack of established guidelines for geriatric use.

Pregnancy

The available prescribing information for Children's TYLENOL (acetaminophen) does not provide specific data regarding its use during pregnancy. There are no explicit statements concerning contraindications or risks to the fetus associated with the use of this medication in pregnant patients. Additionally, the prescribing information does not specify any dosage modifications for individuals who are pregnant. Furthermore, there are no special precautions outlined for the use of this product during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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 a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

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 patients with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The presence of acetaminophen in this formulation necessitates caution, as severe liver damage may occur if the maximum daily dosage of 5 doses within a 24-hour period is exceeded. Additionally, the risk of liver damage is heightened when this product is used concurrently with other medications containing acetaminophen. Therefore, careful monitoring of liver function and adherence to recommended dosing guidelines is essential for patients with compromised liver function.

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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and intervention may be necessary to address any complications that arise from the overdose.

It is vital to maintain open communication with poison control and other medical professionals throughout the management process to ensure optimal care and outcomes for the patient.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Similarly, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any additional insights. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

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. They should be instructed 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.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Additionally, 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. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Healthcare professionals are advised to inspect the packaging carefully; the product must not be used if the carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing, as this may indicate tampering or compromised integrity. Proper handling and storage conditions are essential to ensure the product's safety and effectiveness.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin.

Patients should be advised to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

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.

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