Tylo Extra (acetaminophen)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, backache, minor arthritis pain, toothache, menstrual cramps, and muscular aches. Additionally, it is indicated for the temporary reduction of fever and for the relief of symptoms associated with the common cold.

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 1 caplet every 6 to 8 hours as needed. The total daily dosage must not exceed 4 caplets within a 24-hour period.

For children under 12 years of age, this product is contraindicated. The use of this adult formulation in this age group may result in an overdose, which poses a risk of liver damage. Therefore, it is essential to avoid administering this product to children under 12 years.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

• In individuals with a history of allergic reactions to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while taking this product.

Patients with a history of liver disease should be cautioned to consult a physician prior to use. Additionally, it is essential for patients taking the anticoagulant warfarin to seek guidance from their healthcare provider or pharmacist before using this product, as potential interactions may occur.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: worsening pain or pain that persists beyond 10 days, fever that worsens or lasts longer than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires medical evaluation.

No specific instructions for obtaining emergency medical help are provided; however, healthcare professionals should remain vigilant for signs of severe adverse reactions and advise patients accordingly.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to discontinue use and consult a healthcare professional if they experience worsening pain that lasts more than 10 days, a fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Additionally, individuals with liver disease should seek medical advice before using this product. It is also recommended that patients taking the blood-thinning medication warfarin consult their doctor or pharmacist prior to use to avoid potential interactions.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult their healthcare provider or pharmacist prior to initiating treatment with this drug. This interaction is significant due to the potential for altered anticoagulant effects, which may necessitate dosage adjustments or increased monitoring of coagulation parameters to ensure patient safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it is formulated for adults and may result in an overdose, potentially leading to liver damage. For adolescents aged 12 years and older, the recommended dosage is 1 caplet every 6 to 8 hours, with a maximum of 4 caplets in a 24-hour period. Care should be taken to adhere to these guidelines to ensure safety and efficacy in this age group.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the following limits:

• More than 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications containing acetaminophen.

• Consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the aforementioned risk factors. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, chronic alcohol consumption can exacerbate the potential for liver injury. Specifically, individuals who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk of experiencing severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's condition and consider appropriate management strategies, which may include monitoring liver function and providing supportive care as necessary.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 non-prescription. 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 medication if they have a history of allergic reactions to acetaminophen or any of the inactive ingredients contained 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 liver disease should be encouraged to consult their doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should also be advised to speak with their doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to check the end panel for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

The product is administered orally, with the recommended dosage for adults and children aged 12 years and older being one caplet every 6 to 8 hours. Patients should not exceed a total of four caplets within a 24-hour period.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Tylo Extra (acetaminophen), including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)