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 for pediatric patients aged 2 to 11 years. The product is free from parabens, ibuprofen, alcohol, and aspirin. Each bottle contains 4 fl oz (120 mL) of the suspension, which is presented in a bubble gum flavor. The National Drug Code (NDC) for this formulation is 50580-424-01.

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, 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 squeezed into the enclosed dosing cup, which is specifically designed for use with this product.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses allowed 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 dosing.

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 administered to children 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, healthcare professionals should advise 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 induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Healthcare providers should be vigilant in assessing patients with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

General Precautions Prior to administration, it is essential to consult a physician if the patient has a history of liver disease. Furthermore, healthcare professionals should inquire about the use of anticoagulants, particularly warfarin, as interactions may occur. It is critical to adhere to the recommended dosage and not exceed it during treatment.

In cases of overdose, immediate medical attention is necessary. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is crucial for both adults and children, even in the absence of overt symptoms.

Monitoring and Follow-Up Healthcare professionals should instruct patients to discontinue use and seek medical advice 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 taking this product containing acetaminophen if they exceed five doses in 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.

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 drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, this product is contraindicated in patients with known allergies to acetaminophen or any of the inactive ingredients.

Patients with liver disease should consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional or pharmacist prior to use. It is crucial for patients to adhere to the recommended dosage and to stop use and consult a doctor if pain worsens or persists for more than 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 the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical 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 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 2 years of age should not be given this medication without consulting a healthcare professional. For children aged 2 to 11 years, dosing is weight-based as follows: 5 mL for those weighing 24-35 lbs (2-3 years), 7.5 mL for 36-47 lbs (4-5 years), 10 mL for 48-59 lbs (6-8 years), 12.5 mL for 60-71 lbs (9-10 years), and 15 mL for those weighing 72-95 lbs (11 years). Doses may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period.

Healthcare professionals should be aware of the potential for severe liver damage if more than 5 doses are administered within 24 hours. There is also an allergy alert associated with acetaminophen, which may lead to severe skin reactions, including skin reddening, blisters, and rash. Parents or caregivers should consult a doctor if a child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, it is advisable to seek medical advice before use if the child has liver disease or is taking the anticoagulant warfarin.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center. Prompt medical attention is crucial for pediatric patients, even if no signs or symptoms are initially 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 2-11 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 and therapeutic responses is advisable, given the lack of established guidelines for geriatric use.

Pregnancy

The 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 information does not indicate any required dosage modifications for individuals who are pregnant. Furthermore, no special precautions are outlined for the use of this product during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients on the use of acetaminophen.

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 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 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 of an overdose 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 during the course of treatment.

It is vital to maintain open communication with poison control and other medical professionals to ensure the best possible outcomes for patients experiencing an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

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 ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the packaging carefully; the product should 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 maintain the quality of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, 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 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.

View product document (PDF)