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 the relief of pain and reduction of fever in children aged 2 to 11 years. The product is presented in a 4 fl oz (120 mL) bottle and is dye-free. It is free of alcohol, ibuprofen, aspirin, parabens, high fructose corn syrup, and artificial flavoring. The suspension features a natural apple flavor combined with other natural flavors. The National Drug Code (NDC) for this product is 50580-139-04.

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

Shake the product well before use. Healthcare professionals should determine the appropriate dose based on the patient's weight; if weight is not available, age may be used as a secondary reference.

To administer the dose, remove the child protective cap and dispense the calculated dose into the dosing cup provided. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart should be utilized:

• For patients weighing under 24 lbs (under 2 years), consultation with a physician is advised.

• For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

• For patients weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

• For patients weighing 48-59 lbs (6-8 years), the recommended dose is 10 mL.

• For patients weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

• For patients weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing should only be performed using the enclosed dosing cup specifically designed for this product; other dosing devices are not recommended.

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 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, as it may lead to overdose and associated complications.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen, as this can further increase the risk of liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding sore throat symptoms. If a 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 recommended.

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 other medications, it is advisable to consult a doctor or pharmacist. Furthermore, this product is contraindicated in children with known allergies to acetaminophen or any of the inactive ingredients.

Prior to administration, healthcare professionals should inquire about any existing liver disease in the child. Additionally, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin.

When administering this product, it is crucial to adhere strictly to the recommended dosage to avoid overdose. Should pain worsen or persist beyond five days, or if fever worsens or lasts more than three days, or if new symptoms arise, or if redness or swelling is observed, it is essential to discontinue use and consult a physician, as these may be indicative of a serious condition.

In the event of an overdose, immediate medical attention is necessary. Healthcare professionals should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical 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 who exceed the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, or who take this product in conjunction with other medications containing acetaminophen. Patients should be aware that acetaminophen can cause 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 2 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 a known allergy 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.

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a doctor if pain worsens or persists for more than 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, as 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 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 may be heightened. 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 lbs should consult a doctor before use, while those weighing 24-35 lbs (ages 2-3 years) may receive a dose of 5 mL. For children weighing 36-47 lbs (ages 4-5 years), the recommended dose is 7.5 mL; for those weighing 48-59 lbs (ages 6-8 years), 10 mL is advised. Children weighing 60-71 lbs (ages 9-10 years) should receive 12.5 mL, and those weighing 72-95 lbs (11 years) may take 15 mL. Dosing should primarily be based on weight; if weight is not available, age may be used. No more than 5 doses should be administered in a 24-hour period, with doses repeated every 4 hours as needed while symptoms persist.

Healthcare professionals should be aware of several warnings associated with use in pediatric patients. Severe liver damage may occur if a child exceeds 5 doses in 24 hours or if used concurrently with other acetaminophen-containing medications. Acetaminophen may also cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If a child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is advised. Additionally, it is important to consult a doctor 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, and contacting a Poison Control Center is essential. Quick medical attention is critical for both children and adults.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Children's Tylenol (acetaminophen) during pregnancy. The prescribing information does not mention any safety concerns, dosage modifications, or special precautions related to the use of this product in pregnant patients. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this medication during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

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 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 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 healthcare providers 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. The national Poison Control Center can be reached at 1-800-222-1222. Quick 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 presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. Prompt intervention can significantly impact the outcome in cases of overdose. Therefore, it is essential to follow established protocols for assessment and treatment in such situations.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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.

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. 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, as outlined in the overdose warning. 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 use.

Storage and Handling

The product is supplied in a secure carton, which must remain unopened to ensure integrity. It is essential to verify that the bottle wrap imprinted with “TYLENOL” is intact; do not use the product if this wrap is broken or missing.

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 crucial to preserve the quality and efficacy 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.

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