Tylo Extra

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, backache, minor pain of arthritis, 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 instructed to take 2 caplets every 4 to 6 hours as needed. The total daily dosage must not exceed 8 caplets within a 24-hour period.

This product is contraindicated in children under 12 years of age, as its use in this population may result in an overdose, potentially leading to liver damage.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a history of allergic reactions to acetaminophen or any of the inactive ingredients contained in this formulation.

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 other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

It is essential to exercise caution in specific patient populations. Patients with liver disease should be advised to consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from their doctor 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: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further 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, patients with liver disease should seek medical advice before using this product. It is also recommended that individuals 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. The interaction between this medication 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 Tylo Extra (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 may result in an overdose that could lead to liver damage. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 to 6 hours, with a maximum of 8 caplets in a 24-hour period. Careful adherence to these guidelines is essential to ensure safety and efficacy in this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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. It is essential to evaluate 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

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 that contain acetaminophen.

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

Due to the potential for increased risk of liver damage, 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, the consumption of three or more alcoholic beverages daily while using acetaminophen can exacerbate the risk of 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 the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are essential components of management.

Prompt recognition and intervention are critical to mitigate the potential consequences of acetaminophen overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects reported.

An overdose warning is in place, indicating that exceeding the recommended dose may lead to liver damage. In the event of an overdose, it is crucial to seek medical assistance 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.

No specific details regarding animal pharmacology and toxicology are available.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 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.

Patients should be cautioned against using this medication if they have a history of allergic reactions 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, if their fever intensifies or lasts longer than 3 days, or if they experience the emergence of new symptoms. Additionally, patients should be made aware that the presence of redness or swelling may indicate a serious condition, warranting immediate consultation with a healthcare professional.

It is also essential for patients with liver disease to consult their doctor before using this medication. Furthermore, patients taking the blood-thinning medication warfarin should 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 configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature of 25°C (77°F). For optimal quality assurance, users should refer to the end panel of the packaging to locate the lot number and expiration date. Proper handling and storage conditions are crucial to maintain the integrity 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 Tylo Extra, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)