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Tylenol Extra Strength

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Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1984
Label revision date
January 21, 2026
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1984
Label revision date
January 21, 2026
Manufacturer
Kenvue Brands LLC
Registration number
M013
NDC root
50580-449

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Drug Overview

TYLENOL® is a brand name for acetaminophen, a medication commonly used to relieve pain and reduce fever. It is available in an extra strength formulation, with each caplet containing 500 mg of acetaminophen. You can use TYLENOL® to temporarily alleviate minor aches and pains associated with various conditions, including the common cold, headaches, backaches, toothaches, muscular aches, and menstrual cramps. Additionally, it helps to lower fever, making it a versatile option for managing discomfort and illness.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including the common cold, headaches, backaches, toothaches, and muscular aches. It is also effective for easing minor arthritis pain and alleviating premenstrual and menstrual cramps. Additionally, this medication can help reduce fever temporarily.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 caplets every 6 hours as long as you have symptoms. However, it's important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. Additionally, you should not use this medication for more than 10 days unless directed by your doctor.

For children under 12 years of age, it's best to consult with a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

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 for clarification.

Additionally, avoid using this product if you have a known allergy to acetaminophen or any of its inactive ingredients. Taking these precautions can help ensure your safety and well-being while using this medication.

Side Effects

Taking this medication can lead to some serious side effects, particularly concerning your liver. It's important to avoid exceeding 4,000 mg of acetaminophen in a 24-hour period, using it alongside other acetaminophen-containing products, or consuming three or more alcoholic drinks daily while using this medication, as these actions can significantly increase the risk of severe liver damage.

You should also be aware that acetaminophen can cause severe skin reactions, which may include symptoms like skin reddening, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately. Additionally, if you have liver disease or are taking the blood thinner warfarin, consult your doctor before using this medication. If your pain worsens, lasts more than 10 days, or if you develop a fever that lasts more than 3 days, it's important to stop use and contact a healthcare professional, as these could indicate a more serious condition. In case of an overdose, seek medical assistance right away, even if you don't notice any symptoms.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications that also contain acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

Before using this product, consult your doctor if you have liver disease or are taking the blood thinner warfarin. If you suspect an overdose, it’s crucial to get emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if you don’t notice any symptoms. Additionally, stop using the product and call your doctor if your pain worsens or lasts more than 10 days, your fever worsens or lasts more than 3 days, you develop new symptoms, or if you notice redness or swelling, as these may indicate a serious condition.

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 breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when giving medication to children. For children under 12 years old, you should not use this medication unless directed by a doctor. If your child is 12 years or older, they can take 2 caplets every 6 hours while symptoms last, but they should not exceed 6 caplets in a 24-hour period.

If your child is under 12, always consult a doctor before use. In case of an overdose, seek medical help immediately or contact a Poison Control Center, even if there are no noticeable signs or symptoms. Quick medical attention is crucial for both children and adults.

Geriatric Use

If you are an older adult or a caregiver, it's important to be cautious when using this medication. Before starting, consult your doctor if you have liver disease, as this can affect how your body processes the medication. Additionally, if you are taking warfarin, a common blood thinner, make sure to talk to your doctor or pharmacist before using this medication, as it may interact with your treatment.

It's also crucial to note that you should not use this medication for more than 10 days unless your doctor specifically instructs you to do so. This guideline helps ensure your safety and well-being while using the medication. Always prioritize open communication with your healthcare provider to address any concerns or questions you may have.

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 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 monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver disease, it's important to consult your doctor before using this product. It contains acetaminophen, which can be harmful to your liver. To avoid severe liver damage, do not exceed 4,000 mg of acetaminophen in a 24-hour period. Additionally, be cautious about taking other medications that also contain acetaminophen, as this can increase your risk. If you consume three or more alcoholic drinks daily, you should avoid using this product altogether, as it can further strain your liver. Always prioritize your health and seek guidance from your healthcare provider.

Drug Interactions

It's important to talk to your doctor or pharmacist before using acetaminophen if you are taking warfarin, a blood-thinning medication. This is because acetaminophen can increase the risk of bleeding when used with warfarin.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potential interactions. Your health is a priority, and your provider can help you make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep the carton closed; do not use the product if the carton has been opened. Additionally, check the foil inner seal for the imprint "TYLENOL." If this seal is broken or missing, do not use the product, as it may not be safe.

By following these simple storage and handling guidelines, you can help maintain the quality and safety of your product. Always prioritize these checks to ensure your health and well-being.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is TYLENOL®?

TYLENOL® is a brand name for acetaminophen, which is a pain reliever and fever reducer.

What conditions does TYLENOL® help relieve?

TYLENOL® temporarily relieves minor aches and pains due to the common cold, headache, backache, arthritis, toothache, muscular aches, and menstrual cramps.

What is the recommended dosage for adults?

Adults and children 12 years and over should take 2 caplets every 6 hours while symptoms last, not exceeding 6 caplets in 24 hours, and not using it for more than 10 days unless directed by a doctor.

Can children under 12 years use TYLENOL®?

Children under 12 years should ask a doctor before use.

What should I do in case of an overdose?

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

Are there any warnings associated with TYLENOL®?

Yes, severe liver damage may occur if you take more than 4,000 mg in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using it.

What should I do if I experience a skin reaction?

If you experience symptoms like skin reddening, blisters, or rash, stop using TYLENOL® and seek medical help immediately.

Should I consult a doctor before using TYLENOL®?

Yes, you should ask a doctor before use if you have liver disease or are taking the blood-thinning drug warfarin.

What should I do if my pain or fever worsens?

Stop using TYLENOL® and consult a doctor if your pain worsens or lasts more than 10 days, or if your fever lasts more than 3 days.

Is it safe to use TYLENOL® during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using TYLENOL®.

Packaging Info

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

Packaging configurations for Tylenol Extra Strength.
Details

Drug Information (PDF)

This file contains official product information for Tylenol Extra Strength, 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 temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained 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 following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

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.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Patients should stop using this product and consult a doctor if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These may be indicative of a serious medical condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are unsure if a drug contains acetaminophen are advised to consult a doctor or pharmacist. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use.

Patients with liver disease should consult a doctor prior to using this product. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional before use.

Patients are advised to stop using the product and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Patients taking acetaminophen should consult with a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. The combination may elevate the risk of bleeding due to potential pharmacodynamic interactions. Monitoring of coagulation parameters is advisable in such cases to ensure patient safety.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

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

Packaging configurations for Tylenol Extra Strength.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication unless directed by a healthcare professional. For children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed, with a maximum of 6 caplets in a 24-hour period.

It is essential for children under 12 years to consult a doctor before use. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the treatment. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the blood-thinning medication warfarin, due to potential interactions that could increase the risk of bleeding.

Furthermore, elderly patients are advised not to use this medication for more than 10 days unless specifically directed by a healthcare professional. This precaution is essential to minimize the risk of adverse effects and ensure appropriate monitoring of the patient's condition.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the recommended dosage of acetaminophen, which is limited to a maximum of 4,000 mg within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further elevate the risk of hepatotoxicity.

Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may significantly increase the likelihood of liver damage. Monitoring of liver function is advised for patients with compromised liver function who are prescribed this product.

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 noticeable signs or symptoms.

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

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. Patients should be informed 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 with a doctor or pharmacist.

It is crucial to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with a history of liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to ensure that the foil inner seal, which is imprinted with "TYLENOL," remains intact; the product should not be used if this seal is broken or missing.

Storage conditions require that the product be maintained at a temperature range of 20-25°C (68-77°F) to ensure its efficacy and safety. Proper handling and storage are critical to maintaining the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Tylenol Extra Strength, 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 Tylenol Extra Strength, 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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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.