Childrens Tylenol

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 healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age.

Patients should chew or crush the tablets completely before swallowing; tablets should not be swallowed whole. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides guidance for administration:

• For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by consulting a doctor.

• For patients weighing 24-35 lbs or aged 2-3 years, the recommended dose is 1 tablet.

• For patients weighing 36-47 lbs or aged 4-5 years, the recommended dose is 1½ tablets.

• For patients weighing 48-59 lbs or aged 6-8 years, the recommended dose is 2 tablets.

• For patients weighing 60-71 lbs or aged 9-10 years, the recommended dose is 2½ tablets.

• For patients weighing 72-95 lbs or aged 11 years, the recommended dose is 3 tablets.

Healthcare professionals should ensure that patients do not exceed the recommended dosage and should be aware of the overdose warning associated with this product.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

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.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised. It is crucial to adhere strictly to the recommended dosage to avoid overdose.

General precautions should be observed prior to use. Consultation with a healthcare professional is recommended if the child has a history of liver disease. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin.

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

Healthcare professionals should instruct caregivers to discontinue use and consult a physician 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 there is any redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period. This risk is further heightened if the product is taken concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also discontinue use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before using this product. Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should verify the presence of acetaminophen in any other medications they are taking. Finally, this product should not be used by individuals with known allergies to acetaminophen or any of the inactive ingredients contained within.

Drug Interactions

Severe liver damage may occur if acetaminophen is administered concurrently with other medications containing acetaminophen. It is crucial to avoid the combination of these drugs to prevent potential hepatotoxicity.

In addition, caution is advised when acetaminophen is used in patients who are concurrently taking warfarin, a blood-thinning medication. It is recommended that a healthcare professional be consulted prior to the use of acetaminophen in such cases to ensure safe and effective management of both medications. Monitoring of coagulation parameters may be warranted to assess any potential interactions.

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 may be at risk for severe liver damage if they exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period. It is crucial to avoid administering this product concurrently with other medications containing acetaminophen. Prior to use, healthcare professionals should be consulted if the child has liver disease or is taking the anticoagulant warfarin.

Dosing should be determined using the provided dosage chart, with weight being the preferred method; if weight is unavailable, age may be used. The recommended dosing intervals are every four hours as needed, without exceeding five doses in a 24-hour period. The dosage chart is as follows:

• Under 24 lbs (under 2 years): consult a doctor

• 24-35 lbs (2-3 years): 1 tablet

• 36-47 lbs (4-5 years): 1½ tablets

• 48-59 lbs (6-8 years): 2 tablets

• 60-71 lbs (9-10 years): 2½ tablets

• 72-95 lbs (11 years): 3 tablets

It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is critical for both children and adults, even in the absence of symptoms.

Geriatric Use

Elderly patients should be aware that this product does not contain specific directions or complete warnings for adult use. It is essential for healthcare providers to exercise caution when considering this product for geriatric patients, particularly those aged 65 and older.

In cases where elderly patients have underlying health conditions, such as liver disease, it is advisable to consult a physician prior to use. This precaution is crucial to ensure the safety and appropriateness of the product for this population.

Additionally, quick medical attention is critical for elderly patients in the event of an overdose, even if no signs or symptoms are immediately apparent. Healthcare providers should monitor for any potential adverse effects and be prepared to act swiftly should an overdose occur.

Pregnancy

The available data regarding the use of this medication during pregnancy do not indicate any specific safety concerns. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should consider the absence of explicit risk data when prescribing this medication to pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use of this medication, 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 hepatic impairment. Close monitoring may be warranted to ensure safety and efficacy in this patient 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 noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic effects were identified in the studies conducted. Additionally, there were no reported non-teratogenic effects. The available data does not provide any specific details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance 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 medication if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the product. 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. Similarly, if a fever worsens or lasts longer than three days, patients should be advised to stop use and consult a doctor.

Additionally, patients should be informed to stop using the medication and seek medical attention if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition. It is also important for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist before 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) to maintain its efficacy. Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the foil inner seal, which is imprinted with "TYLENOL," is broken or missing. Proper handling and storage conditions are essential to ensure the integrity of the product.

Additional Clinical Information

Patients should chew or crush the tablets completely before swallowing, as they should not be swallowed whole. The recommended dosing frequency is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

Clinicians are advised to counsel patients to consult a doctor before use if the child has liver disease. Additionally, it is important to seek advice from a doctor or pharmacist if the child is concurrently taking the blood-thinning medication warfarin.

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)