Tylenol Extra Strength

Description

Acetaminophen is an oral suspension formulated to contain 960 mg of acetaminophen per 30 mL. The product is presented in a volume of 8 fl oz (240 mL) and is characterized as dye-free and alcohol-free. It is flavored with cherry.

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 over are instructed to take 30 mL (equivalent to two 15 mL doses) every 6 hours while symptoms persist. The dosing cup should be filled to the 15 mL line twice to achieve the correct dosage. It is imperative not to exceed 3 doses (90 mL) within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, this medication should not be taken for more than 10 consecutive days unless advised by a doctor.

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

Prior to administration, the product must be shaken well. The child protective cap should be removed, and the dose should be squeezed into the enclosed dosing cup, which is specifically designed for use with this product. It is essential to use only the provided dosing cup and not any other dosing device to ensure accurate measurement. Care should be taken to adhere to the recommended dosage to avoid the risk of overdose.

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.

• Known allergy to acetaminophen or any of the inactive ingredients 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 beverages daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a physician 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. It is crucial that patients adhere to the recommended dosage and not exceed it.

In the case of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than 10 days, fever that worsens or persists beyond 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 taking this product containing acetaminophen if they exceed 4,000 mg in a 24-hour period, use it in conjunction with other drugs containing acetaminophen, 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, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is contraindicated for use with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

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

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effect of warfarin, which may lead to an increased risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving both acetaminophen and warfarin to ensure safe and effective management of anticoagulation therapy.

No additional drug interactions or drug and laboratory test interactions have been reported.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The recommended dosing for both adults and children is 30 mL (equivalent to two 15 mL doses) every 6 hours as needed for symptom relief. However, for children under 12 years, it is important not to exceed 3 doses (90 mL) within a 24-hour period unless specifically directed by a physician. Additionally, this medication should not be used for more than 10 days in this age group unless advised by a healthcare provider.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no immediate signs or symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 regarding the excretion of this medication 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 patients 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional prior to use to assess the appropriateness of this medication and to discuss potential risks associated with their liver function. Monitoring of liver function may be warranted in these patients to prevent adverse effects.

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 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, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms 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 about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

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

Patients must be cautioned against exceeding the recommended dose, and they should be made aware of the overdose warning associated with this product. Additionally, patients with liver disease should be advised to consult a doctor before using this medication. Those taking the blood-thinning medication warfarin should also be encouraged 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 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

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)