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Childrens Tylenol

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Active ingredient
Acetaminophen 160 mg
Other brand names
Dosage form
Powder
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
September 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg
Other brand names
Dosage form
Powder
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
September 17, 2025
Manufacturer
Kenvue Brands LLC
Registration number
M013
NDC root
50580-555
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

Children's TYLENOL® is a medication that contains acetaminophen, which is commonly used to relieve minor aches and pains, as well as to reduce fever. It is effective for discomfort associated with conditions like the common cold, flu, headaches, sore throats, and toothaches. This product is designed specifically for children aged 6 to 11 and is both ibuprofen and aspirin free, making it a suitable option for young ones.

The medication comes in convenient dissolve packs that do not require water and dissolve quickly, making it easy for children to take. Each packet contains 160 mg of acetaminophen in a pleasant wild berry flavor, ensuring that your child can manage their pain and fever comfortably.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the common cold, flu, headaches, sore throats, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

When using this product, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. First, check the dosage chart to find the right amount for your child based on their weight or age. If your child weighs between 48 and 59 pounds (or is 6 to 8 years old), you should give them 2 packets of the powder. For children weighing 60 to 71 pounds (or aged 9 to 10 years), the dose remains at 2 packets, while those who weigh between 72 and 95 pounds (or are 11 years old) should receive 3 packets.

To administer the medication, tear open a packet and pour the powder directly onto your child's tongue. You can repeat this dose every 4 hours as long as symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Always be cautious and do not give more than the recommended amount to avoid any risk of overdose.

What to Avoid

It's important to be cautious when using this medication. You should not use it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child is allergic to acetaminophen or any of its inactive ingredients.

While using this medication, make sure to follow the recommended dosage carefully and avoid exceeding it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. It's important not to use this product with any other acetaminophen-containing medications and to seek medical advice if your child has liver disease or is taking blood thinners like warfarin. Always follow the recommended dosage, and if pain or fever worsens or lasts longer than the specified time, contact a healthcare professional. In case of overdose, seek immediate medical assistance.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Before using this product, it's important to ask a doctor if your child has liver disease or is taking the blood thinner warfarin. Always follow the recommended dosage and do not exceed it. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate signs or symptoms.

You should stop using this product and call your doctor if your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling. These could indicate a more serious condition that needs attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked out by a healthcare professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information regarding the use of Children's TYLENOL (acetaminophen) during pregnancy is not specifically detailed. However, the available information does not indicate any safety concerns, dosage changes, or special precautions needed when using this product while pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no particular considerations or precautions mentioned for lactation. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

You should not use this medication in children under 6 years of age. For children aged 6 to 11 years, the recommended dosage varies by weight: those weighing 48-59 pounds should take 2 powders (ages 6-8 years), 60-71 pounds should take 2 powders (ages 9-10 years), and 72-95 pounds should take 3 powders (age 11 years). It's important not to exceed 5 doses in a 24-hour period.

Before giving this medication to your child, consult a doctor if they have liver disease or are taking the blood-thinning drug warfarin. You should also stop use and contact a doctor if your child's pain worsens or lasts more than 5 days, if their fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling. In case of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for children, even if they show no signs of distress.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily designed for children aged 6 to 11 years. Since there are no dosage adjustments or safety concerns noted for elderly patients, you can feel reassured that the product is not expected to pose additional risks for older adults. However, as with any medication, it’s always a good idea to consult with a healthcare provider to ensure it’s appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If your child has liver disease, it’s important to consult a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional advice in these situations.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Acetaminophen may interact with warfarin, which could affect how well it works.

Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness. They can help you understand potential interactions and make informed decisions about your child's health.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness. Always check the packaging before use; if the packet is torn or damaged, do not use the product, as this could compromise its safety and effectiveness.

Handling the product with care is essential. Make sure to keep it in a sterile field (a clean area free from germs) to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your symptoms persist. However, make sure not to exceed 5 doses within a 24-hour period to avoid potential complications. If you have any questions or concerns about your treatment, it's always a good idea to consult with your healthcare provider.

FAQ

What is Children's TYLENOL®?

Children's TYLENOL® is an acetaminophen pain reliever and fever reducer designed for children aged 6-11 years.

What does Children's TYLENOL® do?

It reduces fever and relieves minor aches and pains caused by the common cold, flu, headache, sore throat, and toothache.

How should I administer Children's TYLENOL®?

Tear the packet and pour the powder on your child's tongue. Repeat the dose every 4 hours while symptoms last, but do not exceed 5 doses in 24 hours.

What are the dosage recommendations for Children's TYLENOL®?

For children aged 6-11 years, the dosage is based on weight: 2 powders for 48-59 lbs (ages 6-8), 2 powders for 60-71 lbs (ages 9-10), and 3 powders for 72-95 lbs (age 11).

Are there any contraindications for using Children's TYLENOL®?

Do not use it with any other drug containing acetaminophen or if your child is allergic to acetaminophen or any inactive ingredients in the product.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical.

What are the warnings associated with Children's TYLENOL®?

Severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other acetaminophen-containing drugs. Also, watch for severe skin reactions.

Can I use Children's TYLENOL® if my child has liver disease?

You should consult a doctor before using this product if your child has liver disease.

Is Children's TYLENOL® safe during pregnancy or lactation?

The insert does not provide specific information regarding the use of Children's TYLENOL® during pregnancy or lactation.

How should I store Children's TYLENOL®?

Store it between 20-25°C (68-77°F) and do not use if the packet is torn or damaged.

Packaging Info

Below are the non-prescription pack sizes of Childrens Tylenol (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Tylenol.
Details

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)

Description

No description information is available for the specified drug.

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

For children weighing under 48 lbs or under 6 years of age, the product is not recommended for use. For children weighing between 48-59 lbs (ages 6-8 years), the recommended dose is 2 powders. For those weighing between 60-71 lbs (ages 9-10 years), the recommended dose is also 2 powders. For children weighing between 72-95 lbs (ages 11 years), the recommended dose is 3 powders.

To administer, healthcare professionals should instruct caregivers to tear the packet and pour the powder directly onto the child's tongue. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. Caregivers should be advised to adhere strictly to these guidelines to avoid the risk of overdose.

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, 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.

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 manifest, 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, 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. It is critical to adhere strictly to the recommended dosage and not exceed it during treatment.

In the event of an overdose, immediate medical attention is required. 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.

Discontinuation of Use Healthcare professionals should instruct caregivers to stop the use of this product and consult a physician if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for 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 necessitates further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 5 doses in a 24-hour period, which is the maximum daily amount, or if used 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 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. 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 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, 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 in the absence of noticeable signs or symptoms.

Drug Interactions

Patients should consult a healthcare professional prior to using acetaminophen if they are concurrently taking warfarin, a blood-thinning medication. The combination may lead to potential interactions that could affect the efficacy and safety of warfarin therapy.

Currently, there are no additional drug interactions or laboratory test interactions reported for acetaminophen. Therefore, routine monitoring or dosage adjustments are not indicated beyond the specific interaction with warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Tylenol (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Tylenol.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to 11 years, dosing varies by weight: those weighing 48-59 lbs should receive 2 powders (ages 6-8 years), those weighing 60-71 lbs should receive 2 powders (ages 9-10 years), and those weighing 72-95 lbs should receive 3 powders (age 11 years). The maximum daily amount should not exceed 5 doses within a 24-hour period.

Healthcare professionals should advise parents to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Parents should also be instructed to stop 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 develop, or if redness or swelling occurs.

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

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, and no specific information regarding geriatric use is provided in the prescribing information. The product is primarily intended for children aged 6-11 years.

As there are no dosage adjustments or safety concerns mentioned for elderly patients, healthcare providers should exercise caution when considering the use of this product in geriatric populations. It is advisable to monitor these patients closely, given the lack of data on safety and efficacy in this age group.

Pregnancy

The available prescribing information does not provide specific data regarding the use of Children's TYLENOL (acetaminophen) during pregnancy. As such, there are no stated safety concerns, dosage modifications, or special precautions associated with the use of this product in pregnant patients. Healthcare professionals should consider the absence of specific information when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this product in nursing mothers without specific concerns based on the available information.

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, particularly if they have a history of liver disease. It is essential to assess liver function to determine the appropriateness of treatment and any necessary dosage adjustments. Monitoring of liver function may be required 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 without delay. 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as directed by medical guidelines.

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 these contexts.

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 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 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. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for proper handling and storage. It is crucial to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the product is not used if the packet is torn or damaged, as this may compromise the quality and safety of the contents. Proper adherence to these storage and handling guidelines is vital for optimal product performance.

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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Tylenol, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.