Tylenol

Description

TYLENOL® is a pharmaceutical product containing acetaminophen as its active ingredient. Each tablet has a strength of 325 mg, and the product is classified as a pain reliever and fever reducer. The formulation is available in a dosage form of tablets, with a total of 100 tablets per container. The National Drug Code (NDC) for this product is 50580-495-01.

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 for symptom relief. The maximum dosage should not exceed 10 tablets within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days without medical advice.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake must not exceed 5 tablets, and the duration of use should not exceed 5 days unless directed by a physician.

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:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

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 use.

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 drinks daily while using this product.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, 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 or if the patient is a child experiencing pain due to arthritis. Furthermore, it is recommended to seek guidance from a doctor or pharmacist if the patient is concurrently taking the anticoagulant warfarin.

Emergency Medical Help Instructions

In the event of an overdose, it is critical 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 if no signs or symptoms are initially apparent.

Stop Taking and Call Your Doctor Instructions

Patients should be instructed to stop use 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 underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, while children should not exceed 5 doses within the same timeframe, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks 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, patients are advised to discontinue use immediately and seek medical assistance.

Patients are cautioned against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Patients should discontinue use and consult a doctor if pain worsens or persists beyond 10 days in adults, or if pain lasts more than 5 days in children under 12 years. Furthermore, 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 advisable for patients to consult a doctor prior to use if they have liver disease or if a child is experiencing pain due to arthritis. Additionally, patients taking the blood-thinning medication warfarin should seek guidance from a healthcare professional before using this product.

In cases of overdose, it is critical for patients to obtain medical help or contact a Poison Control Center immediately. 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 may use this medication with specific dosing considerations. For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, not to exceed 5 tablets (1,625 mg) in a 24-hour period. It is important to note that the medication should not be used for more than 5 days unless directed by a healthcare professional.

For children under 6 years of age, it is advised to consult a doctor before use to ensure safety and appropriateness of treatment.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined for the use of this medication. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations for pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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. 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, particularly if they have a history of liver disease. The product contains acetaminophen, which necessitates careful consideration of dosing limits to prevent severe liver damage.

For adults, the maximum daily dose is limited to 10 tablets (3,250 mg) within a 24-hour period. However, it is critical to note that exceeding 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. For pediatric patients, the maximum daily dose is restricted to 5 tablets (1,625 mg) in 24 hours, and exceeding this amount may also result in significant liver injury.

Additionally, patients should be aware of the risks associated with concurrent use of other medications containing acetaminophen, as this can further increase the likelihood of liver damage. Alcohol consumption should also be considered; adults who consume 3 or more alcoholic drinks daily while using this product are at an elevated risk for liver damage.

Monitoring of liver function may be warranted in patients with compromised liver function, and any signs of liver injury should prompt immediate medical evaluation.

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 severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include the following steps:

1. Assessment of Symptoms: Continuous monitoring for any potential symptoms associated with the overdose is necessary. Symptoms may not be immediately apparent, thus vigilance is required.

2. Supportive Care: Provide supportive care as needed, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

3. Decontamination: If appropriate and within the timeframe, consider decontamination measures such as activated charcoal, following established protocols.

4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered as per established guidelines.

5. Hospitalization: Depending on the severity of the overdose and the patient's condition, hospitalization may be warranted for further observation and treatment.

In summary, immediate action and comprehensive management are essential in cases of overdose to mitigate potential complications 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions 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 product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. 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 of age. 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.

Patients should also be made aware that the presence of redness or swelling may indicate a serious condition, warranting immediate medical attention. It is essential to recommend that patients consult a doctor before using this medication if they have liver disease or if they are a child experiencing pain due to arthritis. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to 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; do not use the product 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 experiences.

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)