Childrens Tylenol

Description

Children's TYLENOL® is an oral suspension containing acetaminophen at a concentration of 160 mg per 5 mL. This formulation is designed for use in pediatric patients aged 2 to 11 years and is indicated as a pain reliever and fever reducer. The product is packaged in a 4 fl oz (120 mL) bottle and is intended for in-patient use only within hospital or government settings, and is not available for retail sale. The suspension is alcohol-free, ibuprofen-free, aspirin-free, and does not contain parabens. It is flavored with grape to enhance palatability. The National Drug Code (NDC) for this product is 50580-579-02.

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 an alternative.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be poured into the enclosed dosing cup, which is specifically designed for use with this product.

Dosing should be repeated every 4 hours as needed while symptoms persist, but it is critical not to 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 or aged 2-3 years, the dose is 5 mL.

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

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

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

• For children weighing 72-95 lb or aged 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.

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 other medications, consultation with a healthcare professional is advised.

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

• Exceeding the recommended dosage while using this product is contraindicated due to the risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, liver damage may occur if a child takes more than 5 doses within a 24-hour period or if it 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 occur, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

General Precautions This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is advised. Additionally, this product is contraindicated in children with known allergies to acetaminophen or any of its inactive ingredients.

Healthcare professionals should advise parents to consult a doctor prior to use if their child has liver disease or is currently taking the anticoagulant warfarin. It is crucial to adhere strictly to the recommended dosage and not to exceed it.

Emergency Medical Help In the event of an overdose, immediate medical attention is necessary. Contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients should be instructed to stop using this product and consult a healthcare provider if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum recommended dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be aware that acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate 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 promptly.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist if uncertain. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Before administering this product, it is advisable for patients to consult a healthcare provider if there is a history of liver disease or if the patient is taking the anticoagulant warfarin.

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and seek medical advice if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are 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 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 Tylenol (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lb should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lb, the recommended dose is 5 mL; for those aged 4 to 5 years weighing 36-47 lb, the dose is 7.5 mL; for children aged 6 to 8 years weighing 48-59 lb, the dose is 10 mL; for those aged 9 to 10 years weighing 60-71 lb, the dose is 12.5 mL; and for children aged 11 years weighing 72-95 lb, the dose is 15 mL. Dosing should primarily be based on weight; if weight is not available, age may be used. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Pediatric patients are at risk for severe liver damage if more than 5 doses are administered within 24 hours. It is advised to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. Parents or caregivers should discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center. Prompt medical attention is crucial for children, even if no signs or symptoms of overdose are apparent.

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 to 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 targeted studies in geriatric patients.

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

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 text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns.

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 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 patient exceeds five doses within a 24-hour period, which is the maximum recommended daily amount. 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 dosing guidelines is essential to mitigate the risk of hepatotoxicity in 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 intervention is crucial for both adults and children, even in the absence of observable 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 of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential 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 question.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued and medical assistance be sought immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial 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 the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is important to emphasize that patients should not exceed the recommended dosage, as this could lead to an overdose. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in packaging that includes a carton and a bottle, both of which must remain intact. Specifically, the carton tape and bottle wrap should not be broken or missing if the product is to be used.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)