Tylenol

Description

TYLENOL® is a pharmaceutical product containing acetaminophen as its active ingredient, formulated at a strength of 325 mg. This regular strength formulation is presented in the form of caplets, with a package size of 100 caplets. The product is packaged in a special EZ DOSE™ design, consisting of 10 blister cards, each containing 10 individual blisters. The National Drug Code (NDC) for this product is 50580-600-02. TYLENOL® is indicated as a pain reliever and fever reducer, and it is specifically intended for hospital and government use only. The packaging is designed with a focus on healthcare professionals, ensuring smart and efficient dispensing.

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 advised to take 2 caplets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 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 instructed by a doctor.

For children aged 6 years to under 12 years, the recommended dosage is 1 caplet every 4 to 6 hours while symptoms persist. The total daily intake must not exceed 5 caplets, 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 essential 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, 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 is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within the 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 use.

Warnings

The maximum daily dose for adults is 10 caplets (3,250 mg) within a 24-hour period, while for children, it is limited to 5 caplets (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, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions 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 guidance from a doctor or pharmacist if the patient is concurrently taking the blood-thinning medication 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 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, 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 patient 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, it is imperative to discontinue use and seek medical assistance immediately.

Acetaminophen should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications are advised to consult a doctor or pharmacist. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in the 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 doctor or pharmacist before use.

Patients are advised to discontinue use and consult a doctor 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, including redness or swelling, medical consultation is recommended, as these may indicate a serious condition.

In the event of an overdose, it is crucial for patients to seek 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 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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

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 are advised to take 1 caplet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 caplets (1,625 mg) in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years, consultation with a doctor is required prior to use.

It is important to note that exceeding the maximum daily dose of 5 caplets may result in severe liver damage. Therefore, careful adherence to dosing guidelines is essential to ensure safety in pediatric patients.

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 medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

For elderly patients, it is crucial to adhere to the recommended dosage guidelines. The maximum dosage should not exceed 10 caplets within a 24-hour period unless specifically directed by a healthcare professional. Furthermore, the use of this medication should not extend beyond 10 days unless advised by a doctor, to mitigate 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 safe use during pregnancy and lactation.

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.

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 advised 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 health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with 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.

No relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

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 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 included in the formulation. Healthcare providers should instruct patients 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, patients should be advised to stop use and consult a doctor if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is also essential for healthcare providers to recommend that patients consult a doctor before using this medication if they have liver disease. 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 individual blister units. Each blister must remain intact; do not use if any individual blister unit is open or torn.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). It is essential to avoid high humidity conditions and to protect the product from light to ensure its integrity and efficacy.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 caplets every 4 to 6 hours as needed for symptom relief, with a maximum of 10 caplets in a 24-hour period unless otherwise directed by a physician. The use of this medication should not exceed 10 days without medical guidance. For children aged 6 to under 12 years, the recommended dosage is 1 caplet every 4 to 6 hours, not to exceed 5 caplets in 24 hours, and should not be used for more than 5 days unless directed by a healthcare provider. For children under 6 years, consultation with a doctor is recommended prior to administration.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, 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)