Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Childrens Tylenol

Last content change checked dailysee data sync status

Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
November 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
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 2017
Label revision date
November 7, 2024
Manufacturer
Kenvue Brands LLC
Registration number
M013
NDC root
50580-509
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Children's TYLENOL is an oral suspension that contains acetaminophen (160 mg per 5 mL) and is designed to relieve pain and reduce fever in children aged 2 to 11 years. It is effective for alleviating minor aches and pains associated with common conditions such as the cold, flu, headache, sore throat, and toothache.

This medication is free from parabens, ibuprofen, alcohol, and aspirin, making it a gentle option for young children. It comes in a pleasant strawberry flavor, making it easier for kids to take.

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 cold and flu, as well as headaches, sore throats, and toothaches.

This medication is designed to provide you with relief when you're feeling unwell, making it easier to manage everyday discomforts.

Dosage and Administration

Before using this product, make sure to shake it well. You’ll need to measure the correct dose based on your child's weight or age. If your child weighs less than 24 pounds or is under 2 years old, it’s best to consult a doctor for the appropriate dosage. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 5 milliliters (mL). If your child is 4 to 5 years old and weighs between 36 and 47 pounds, the dose increases to 7.5 mL. For children aged 6 to 8 years weighing 48 to 59 pounds, the dose is 10 mL, and for those aged 9 to 10 years weighing 60 to 71 pounds, it’s 12.5 mL. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 15 mL.

When giving the medication, remove the child protective cap and squeeze the measured dose into the enclosed dosing cup. You can repeat this dose every 4 hours as long as your child continues to have symptoms, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide accurate measurements.

What to Avoid

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

While using this product, make sure to follow the recommended dosage and never exceed it. This helps ensure safety and effectiveness while minimizing the risk of potential side effects.

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. Always check with a doctor if your child has liver disease or is taking blood thinners like warfarin. If pain or fever worsens or lasts longer than the recommended time, or if new symptoms appear, stop use and contact a healthcare professional. In case of overdose, seek medical assistance immediately.

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 skin reactions, 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. In case of an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222, as quick attention is crucial for both adults and children, even if no symptoms are present. You should also stop using the product and call your doctor if your child's pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling, as these could indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick medical attention 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 or have concerns about a possible overdose, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 limited. The insert does not provide specific guidance on its use, nor does it mention any risks to the fetus or contraindications. Additionally, there are no recommended dosage modifications for pregnant individuals, and no special precautions are outlined.

While there are no explicit warnings, it's always 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 or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercise caution when considering this product while nursing, as your baby's safety is a top priority.

Pediatric Use

When giving this medication to your child, it's important to follow the recommended dosages based on their weight and age. For children under 2 years who weigh less than 24 pounds, consult your doctor before use. For those aged 2 to 3 years and weighing between 24-35 pounds, the dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 pounds), 10 mL for ages 6-8 years (48-59 pounds), 12.5 mL for ages 9-10 years (60-71 pounds), and 15 mL for 11-year-olds (72-95 pounds). Remember, do not exceed 5 doses in a 24-hour period, as taking more can lead to severe liver damage.

If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before administering the medication. In case of an overdose, seek medical help immediately, even if your child shows no symptoms. Always use the dosing cup provided with the medication to ensure accurate measurement, and avoid using any other devices for dosing.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily indicated for children aged 2 to 11 years. This means that if you are caring for an older adult, there are no established dosage adjustments or safety concerns specifically related to their age mentioned in the product information.

As always, it’s important to consult with a healthcare professional before starting any new medication, especially for older adults who may have unique health considerations or take multiple medications. Your healthcare provider can help ensure that the treatment is safe and appropriate for their specific needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If your child has liver disease, it’s important to consult with 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 guidance 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 medication. Mixing these can increase the risk of bleeding, so it's crucial to ensure safety.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Always prioritize open communication about any medications you or your child are taking to prevent potential interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its quality. Before using, check that the carton tape or bottle wrap marked with "TYLENOL" is intact. If it is broken or missing, do not use the product, as this could indicate that it has been tampered with or is no longer safe.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe for your use.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

If your child's pain worsens or lasts more than 5 days, or if a fever worsens or lasts more than 3 days, stop using the medication and contact a doctor. Additionally, seek medical advice if new symptoms appear or if there is any redness or swelling.

FAQ

What is Children's TYLENOL?

Children's TYLENOL is an oral suspension containing acetaminophen (160 mg per 5 mL) that acts as a pain reliever and fever reducer.

What age group is Children's TYLENOL suitable for?

Children's TYLENOL is indicated for use in children aged 2 to 11 years.

What symptoms does Children's TYLENOL help relieve?

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

How should I administer Children's TYLENOL?

Use the enclosed dosing cup to measure the dose based on your child's weight or age, and do not exceed 5 doses in 24 hours.

What are the dosage recommendations for Children's TYLENOL?

For children weighing under 24 lb, consult a doctor. For those weighing 24-35 lb, the dose is 5 mL; 36-47 lb is 7.5 mL; 48-59 lb is 10 mL; 60-71 lb is 12.5 mL; and 72-95 lb is 15 mL.

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, seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

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

You should ask a doctor before using Children's TYLENOL if your child has liver disease.

Is it safe to use Children's TYLENOL during pregnancy?

The insert does not provide specific information regarding the use of Children's TYLENOL during pregnancy, so consult a doctor.

What should I do if my child's symptoms persist?

Stop use and consult a doctor if pain lasts more than 5 days or fever lasts more than 3 days, or if new symptoms occur.

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

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 children aged 2 to 11 years and serves as a pain reliever and fever reducer. The product is free from parabens, ibuprofen, alcohol, and aspirin. It is presented in a 4 fl oz (120 mL) bottle with a strawberry flavor. The National Drug Code (NDC) for this product is 50580-509-01.

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 as follows: the dose may be repeated every 4 hours while symptoms persist, but it is imperative 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 (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 crucial to use only the enclosed dosing cup and not any other dosing device to ensure accurate measurement and administration.

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 product, as this may lead to severe allergic reactions.

  • Exceeding the recommended dose while using this product is contraindicated, as it may increase the risk of adverse effects.

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, as this may further increase the risk of liver injury.

Allergy Alert Acetaminophen may induce 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 where a sore throat is severe, persists beyond 2 days, or is 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, as interactions may occur.

Emergency Medical Help In the event of an overdose, immediate medical attention is critical. Caregivers should contact a Poison Control Center (1-800-222-1222) without delay, regardless of whether symptoms are present, as rapid intervention is crucial for both adults and children.

Discontinuation and Consultation Caregivers should be instructed to stop use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within 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 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 uncertain about the presence of acetaminophen in other medications should consult a doctor or pharmacist. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Patients with liver disease should seek medical advice before using this product. Furthermore, those taking the anticoagulant warfarin should consult a healthcare provider or pharmacist prior to use. It is crucial for patients to adhere to the recommended dosage and to refrain from exceeding it, as outlined in the overdose warning.

Patients should discontinue use and consult a doctor if pain worsens or persists beyond 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, even if no signs or symptoms are apparent. Quick medical intervention is critical for both adults and children.

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.

Packaging configurations for Childrens Tylenol.
Details

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 dosage is 5 mL. For those aged 4 to 5 years weighing 36-47 lb, the dosage increases to 7.5 mL. Children aged 6 to 8 years weighing 48-59 lb should receive 10 mL, while those aged 9 to 10 years weighing 60-71 lb should be given 12.5 mL. For children aged 11 years weighing 72-95 lb, the recommended dosage is 15 mL.

It is critical not to exceed 5 doses within a 24-hour period, as severe liver damage may occur with higher dosages. Parents and caregivers should consult a doctor prior to use if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt attention is essential for pediatric patients, even if no symptoms are apparent.

Dosing should primarily be based on the child's weight; if weight is not available, age may be used as a secondary guide. Only the enclosed dosing cup designed for this product should be utilized, and no other dosing devices should be employed.

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 related to elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the lack of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, given the absence of established guidelines for use in individuals aged 65 and older.

Pregnancy

The available prescribing information does not provide specific data regarding the use of Children's TYLENOL (acetaminophen) during pregnancy. There are no explicit statements concerning contraindications or risks to the fetus associated with its use. Additionally, no dosage modifications for pregnant individuals are specified, and the insert does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of detailed risk data when advising pregnant patients and weigh the benefits against any potential unknown risks.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful assessment and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this 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 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 amount and type of 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 specific clinical presentation. Continuous evaluation and intervention may be necessary to address any complications that arise during the course of treatment.

In summary, timely intervention and appropriate management are vital in cases of overdose to mitigate potential risks and ensure patient safety.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance promptly.

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 that this product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with 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. 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 or is currently taking the anticoagulant medication warfarin.

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, as this indicates that the product may not be safe for use.

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

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the patient has liver disease or is taking the blood-thinning medication warfarin. Additionally, patients should be advised to 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)

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.

Learn more in our Editorial Policy

Last AI update:

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.