Tylenol

Description

TYLENOL® is a pharmaceutical formulation containing acetaminophen as the active ingredient, classified as a pain reliever and fever reducer. Each tablet contains 325 mg of acetaminophen. The product is available in a regular strength dosage form, with a total of 100 tablets per container. The National Drug Code (NDC) for this product is 50580-496-98.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, 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 tablets every 4 to 6 hours as needed while symptoms persist. The maximum dosage should not exceed 10 tablets 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 aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last. The total daily intake must not surpass 5 tablets, and the duration of use should not exceed 5 days unless directed by a healthcare provider.

For children under 6 years of age, it is advised to consult a doctor before administration.

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, and it is crucial for healthcare professionals to be aware of the associated warnings and precautions to ensure safe usage.

Warnings

The maximum daily dose for adults is 10 tablets (3,250 mg) within a 24-hour period, while for children, it is limited to 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances:

• An adult consumes more than 4,000 mg of acetaminophen in 24 hours.

• A child exceeds 5 doses in 24 hours, which is the maximum daily amount.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic beverages daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms can include skin reddening, blisters, and rash. If any skin reaction occurs, it is imperative to discontinue use and seek medical assistance immediately.

General Precautions

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease. Furthermore, it is recommended to seek medical advice if the user is a child experiencing pain due to arthritis. Patients taking the anticoagulant warfarin should also consult a doctor or pharmacist before using this product.

Emergency Medical Help Instructions

In the event of an overdose, immediate medical help should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Stop Taking and Call Your Doctor Instructions

Patients should be instructed to stop using the product and consult a doctor if any of the following occur:

• Pain worsens or persists for more than 10 days in adults.

• Pain worsens or lasts more than 5 days in children under 12 years.

• Fever worsens or lasts more than 3 days.

• New symptoms develop.

• Redness or swelling is observed.

These symptoms may indicate a serious condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, or if a child exceeds 5 doses in the same timeframe. This risk is heightened when acetaminophen is taken in conjunction with other medications containing the same active ingredient or when an adult consumes three or more alcoholic beverages daily while using this product.

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

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Those with known allergies to acetaminophen or any inactive ingredients in the formulation should also refrain from use.

Patients should stop using the product and consult a healthcare professional if pain worsens or persists beyond 10 days in adults, or beyond 5 days in children under 12 years. Additionally, if fever worsens or lasts more than 3 days, or if new symptoms arise, medical advice should be sought. The presence of redness or swelling may indicate a serious condition, warranting immediate medical attention.

It is recommended that patients consult a healthcare provider prior to use if they have liver disease, if they are children experiencing pain from arthritis, or if they are taking the anticoagulant warfarin.

In cases of overdose, it is critical to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this product. The interaction between this product and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years to under 12 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets (1,625 mg) in a 24-hour period. Use should not exceed 5 consecutive days unless directed by a healthcare professional. For children under 6 years, it is advised to consult a doctor prior to use. In cases where pain worsens or persists for more than 5 days in children under 12 years, discontinuation of use is recommended, and a healthcare provider should be consulted.

Geriatric Use

Elderly patients may not have specific dosage adjustments or safety concerns outlined in the prescribing information. However, it is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, particularly those with underlying health conditions.

Healthcare providers should advise elderly patients to consult a physician prior to use if they have a history of liver disease. This precaution is critical, as liver function can significantly impact the metabolism and clearance of medications, potentially leading to increased risks of adverse effects in this population. Regular monitoring and assessment of liver function may be warranted in geriatric patients to ensure safe and effective use of the medication.

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are essential for patients with compromised liver function to prevent potential adverse effects.

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 adverse effects. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Management of an overdose may involve supportive measures and symptomatic treatment, tailored to the specific circumstances and clinical presentation of the patient. Continuous assessment and vigilance are necessary to ensure optimal outcomes.

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 their other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the product. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be advised to stop use and consult a healthcare professional.

It is essential to inform patients to seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. Patients with liver disease should be advised to consult a doctor before using this medication. Furthermore, if the patient is a child experiencing pain due to arthritis, they should also be encouraged to seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be instructed to consult with a doctor or pharmacist before using this product.

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," is intact; the product should not be used if this seal 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 ensure the integrity and efficacy 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 experience.

Drug Information (PDF)

This file contains official product information for Tylenol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)