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Childrens Tylenol

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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
50580-170
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Children's TYLENOL® is an oral suspension that contains acetaminophen (160 mg per 5 mL) and is designed for children aged 2 to 11 years. This medication is primarily used to reduce fever and relieve minor aches and pains associated with common conditions such as the cold, flu, headaches, sore throats, and toothaches.

This product is dye-free and does not contain alcohol, ibuprofen, aspirin, parabens, or high fructose corn syrup, making it a gentle option for your child's needs. It comes in a pleasant cherry flavor and is available in an 8 fl oz (240 mL) bottle.

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 medication, make sure to shake the bottle well. You’ll need to measure the correct dose based on your child's weight or age. For children under 2 years old, it’s best to consult a doctor for the appropriate dosage. If your child weighs between 24 and 35 pounds (2-3 years old), the dose is 5 milliliters (mL). For those weighing 36 to 47 pounds (4-5 years), the dose increases to 7.5 mL, and for 48 to 59 pounds (6-8 years), it’s 10 mL. Children who weigh 60 to 71 pounds (9-10 years) should receive 12.5 mL, while those at 72 to 95 pounds (11 years) can take 15 mL.

When administering the medication, remove the child-proof cap and pour the measured dose into the dosing cup provided. 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 to ensure accuracy, and avoid using any other measuring devices.

What to Avoid

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

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always be mindful of these guidelines to ensure safe use of the medication.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. Severe liver damage may occur if your child takes more than five doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, be cautious of potential severe skin reactions, which can include symptoms like skin reddening, blisters, or rashes. If any of these occur, stop using the medication and seek medical help immediately.

You should also consult a doctor if your child has a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. If pain or fever worsens or lasts longer than the specified time frames, or if new symptoms arise, it's important to stop use and contact a healthcare professional. Always seek immediate medical attention in case of an overdose, even if no symptoms are present.

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-thinning medication warfarin. Always follow the recommended dosage and do not exceed it. If you suspect 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 also stop using the product and call your doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these may 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 it’s essential to act quickly. Always err on the side of caution and get help right away if you think an overdose may have occurred. Remember, timely intervention can make a significant difference in outcomes.

Pregnancy Use

You can generally use Children's Tylenol (acetaminophen) during pregnancy, as there are no specific warnings or precautions mentioned regarding its use. The information provided does not indicate that it is contraindicated for pregnant individuals, nor does it suggest any necessary dosage modifications or safety concerns.

However, it's always a good idea to consult with your healthcare provider before taking any medication while pregnant to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of acetaminophen on babies who are breastfed haven't been thoroughly studied, it's best to be cautious and seek professional advice to ensure the safety of both you and your child.

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 old who weigh less than 24 lbs, you should consult a doctor before use. For those aged 2-3 years and weighing 24-35 lbs, the dose is 5 mL, while children aged 4-5 years and weighing 36-47 lbs should receive 7.5 mL. As your child grows, the dosage increases: 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs). Remember, do not exceed 5 doses in a 24-hour period, as taking too much can lead to severe liver damage.

Be aware of potential warnings: if your child has liver disease or is taking the blood-thinning medication warfarin, consult a doctor before use. Additionally, watch for any severe skin reactions, such as redness or blisters, and seek medical help immediately if they occur. If your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by other symptoms like fever or rash, contact a doctor. In case of an overdose, it's crucial to get medical help right away, even if there are no immediate symptoms.

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 noted for this age group.

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. They can provide guidance tailored to individual health needs and ensure safe use.

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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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.

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 contains 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). It's important to keep the carton unopened; do not use the product if the carton has been opened. Additionally, check the bottle wrap for the imprint “TYLENOL.” If this wrap is broken or missing, do not use the product, as it may compromise safety.

By following these simple storage and handling guidelines, you can help maintain the quality and safety of your product.

Additional Information

No further information is available.

FAQ

What is Children's TYLENOL®?

Children's TYLENOL® is an acetaminophen (160 mg per 5 mL) oral suspension used to reduce fever and relieve minor aches and pains.

What age group is Children's TYLENOL® suitable for?

This product is suitable for children aged 2 to 11 years.

What are the main uses of Children's TYLENOL®?

It is used to reduce fever and relieve minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache.

What should I do if my child has a severe sore throat?

If your child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

How should I dose Children's TYLENOL®?

Dosing should be based on your child's weight if possible; otherwise, use their age. Refer to the dosing chart for specific amounts.

What is the maximum number of doses I can give in 24 hours?

Do not give more than 5 doses in 24 hours.

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.

Are there any allergies associated with Children's TYLENOL®?

Yes, acetaminophen may cause severe skin reactions. If you notice symptoms like skin reddening, blisters, or rash, stop use and seek medical help.

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

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

Is it safe to use Children's TYLENOL® while breastfeeding?

Nursing mothers should consult a doctor before using this product, as acetaminophen may be excreted in breast milk.

What should I do if my child's pain or fever worsens?

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

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 as a pain reliever and fever reducer for pediatric patients aged 2 to 11 years. The product is presented in an 8 fl oz (240 mL) bottle and features a cherry flavor. It is formulated to be free of dyes, alcohol, ibuprofen, aspirin, parabens, and high fructose corn syrup, ensuring a suitable option for children with specific dietary restrictions.

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 dosing chart provided, with weight being the preferred method for dosing; if weight is not available, age may be used as a secondary reference.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period.

Dosing Chart:

  • For children weighing under 24 lbs or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

It is essential 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 formulation, as this may lead to severe allergic reactions.

  • Exceeding the recommended dose is contraindicated due to the potential for overdose and associated health risks.

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 lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, 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 recommended.

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Furthermore, healthcare professionals should inquire about the use of blood-thinning medications, such as warfarin, as this may influence the safety of acetaminophen use. It is critical to adhere to the recommended dosage and not exceed it.

Emergency Medical Help Instructions In the event of an overdose, immediate medical attention is essential. Healthcare providers should instruct caregivers to contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Stop Taking and Call Your Doctor Instructions Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain or pain lasting more than 5 days, worsening fever or fever lasting 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 requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who take the medication concurrently with other drugs 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 two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

This medication 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.

Before using this medication, patients with liver disease should consult a healthcare provider. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a healthcare professional 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, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are immediately 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.

Packaging configurations for Childrens Tylenol.
Details

Pediatric Use

Pediatric patients under 24 lbs (under 2 years) should consult a doctor before use. For those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL; for 36-47 lbs (4-5 years), 7.5 mL; for 48-59 lbs (6-8 years), 10 mL; for 60-71 lbs (9-10 years), 12.5 mL; and for 72-95 lbs (11 years), 15 mL. Dosing should ideally be based on weight; if weight is not available, age may be used as a guide.

Healthcare professionals should advise parents and caregivers not to exceed 5 doses in a 24-hour period, as exceeding the maximum daily amount may lead to severe liver damage. An allergy alert is warranted, as acetaminophen can cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Consultation with a healthcare provider is recommended if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center is advised, as prompt medical attention is critical for both children and adults, even if no symptoms are present.

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 primarily indicated for children aged 2 to 11 years, and there are no documented dosage adjustments or safety concerns specifically related to elderly patients.

Healthcare providers should exercise caution when considering this product for geriatric patients, given the absence of data. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as individual responses may vary.

Pregnancy

The use of Children's Tylenol (acetaminophen) during pregnancy does not have specific warnings or precautions outlined in the prescribing information. There are no indications that the product is contraindicated for use in pregnant patients, nor are there any dosage modifications or safety concerns explicitly noted for this population. Healthcare professionals should consider the overall clinical context when recommending acetaminophen to pregnant individuals, taking into account the absence of documented risks associated with its use during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

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 and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests 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 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 comprehensive care as needed.

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.

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 whether a drug contains acetaminophen, 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 present 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. Lastly, 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 of this product.

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

No further data are available.

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.