Tylo Migraine (acetaminophen)

Description

Tylo Migraine contains acetaminophen as its active ingredient, with a dosage strength of 250 mg per unit. Acetaminophen is a widely used analgesic and antipyretic agent. The formulation is designed for the management of migraine symptoms.

Uses and Indications

This drug is indicated for the relief of migraine.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper absorption.

For adults and children aged 12 years and older, the recommended dosage is two tablets every 6 hours, with a maximum of 8 tablets within a 24-hour period.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is also contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Aspirin, a component of this product, may provoke severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention should be sought if any of these symptoms occur.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 tablets within a 24-hour period (the maximum daily dosage), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this formulation raises the potential for severe stomach bleeding. The risk is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, users of blood-thinning medications or steroids, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), and those who consume three or more alcoholic drinks daily while using this product. Additionally, taking more than the recommended dosage or for an extended duration increases the risk of stomach bleeding.

Caffeine is also present in the recommended dose of this product, approximately equivalent to that found in a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Users should discontinue use and consult a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), if migraine symptoms are not alleviated or worsen after the first dose, if new or unexpected symptoms arise, or if there is ringing in the ears or loss of hearing.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may be serious.

Serious Adverse Reactions Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these may be early signs of Reye’s syndrome.

A severe allergic reaction to aspirin may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical help immediately.

This product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking blood thinners, steroids, or other NSAIDs. Patients should be informed of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common Adverse Reactions Patients may also experience less severe but common adverse reactions. The recommended dose of this product contains caffeine, which is comparable to that found in a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Monitoring and Consultation Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, stomach bleeding, or if their migraine is not relieved or worsens after the first dose. New or unexpected symptoms, as well as ringing in the ears or loss of hearing, should also prompt a consultation with a healthcare professional.

Before using this product, patients should seek medical advice if they have never had migraines diagnosed by a health professional, have a headache that differs from their usual migraines, or if they experience the worst headache of their life, fever with a stiff neck, or headaches following head injury, exertion, coughing, or bending. Additional caution is warranted for patients over 50 experiencing their first headache, those with daily headaches, severe migraines requiring bed rest, liver disease, or a history of stomach problems. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or other medications should also consult a doctor prior to use.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the simultaneous use of these products to mitigate the risk of hepatotoxicity.

The concomitant use of this product with anticoagulants, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen significantly increases the risk of severe gastrointestinal bleeding. Caution is recommended, and healthcare providers should consider monitoring for signs of bleeding in patients who require the use of these medications together.

Additionally, the intake of caffeine-containing medications, foods, or beverages should be limited while using this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, tachycardia. Patients are advised to monitor their caffeine intake to avoid these potential side effects.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. For children under 12 years, it is advised to consult a doctor before use.

For dosing, adults and children aged 12 years and over may take two tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this product. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding and to consider alternative therapies if necessary.

Additionally, in geriatric patients with liver disease, the safety profile of this product may be compromised. Therefore, it is crucial for healthcare providers to consult with a physician regarding the use of this product in elderly patients with hepatic impairment to ensure appropriate management and monitoring.

Pregnancy

Pregnant patients or those who are breastfeeding should be advised to consult their healthcare provider before 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 discuss their pregnancy status and any plans for pregnancy with their healthcare provider to ensure appropriate management and monitoring during treatment.

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

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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential risk of severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of hepatotoxicity.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly elevate the risk of liver damage. Therefore, careful consideration and monitoring of liver function are essential for patients with hepatic impairment to prevent adverse effects.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has indicated that the following adverse reactions may occur: allergic reactions, which include hives, facial swelling, asthma (wheezing), and shock. Additionally, reports have emerged regarding severe liver damage associated with the use of acetaminophen, particularly in instances of overdose or when used in conjunction with other products containing acetaminophen.

There have also been reports of severe stomach bleeding linked to the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, especially in patients over 60 years of age or those with a history of stomach ulcers or bleeding disorders. Furthermore, new or unexpected symptoms, such as tinnitus (ringing in the ears) or hearing loss, have been documented in the postmarketing experience.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, emphasizing the importance of seeking medical help without delay. Additionally, patients should be informed to stop use and contact a healthcare professional if they notice any symptoms indicative of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if their migraine is not alleviated or worsens after the first dose. New or unexpected symptoms, as well as ringing in the ears or loss of hearing, should also prompt patients to seek medical advice.

It is essential for healthcare providers to encourage patients to consult a doctor before using the medication if they have never had a migraine diagnosed by a health professional, if they experience a headache that differs from their usual migraines, or if they have the worst headache of their life. Patients should also be advised to seek medical guidance if they have fever and a stiff neck, headaches that begin after or are caused by head injury, exertion, coughing, or bending, or if they experience their first headache after the age of 50. Those with daily headaches, migraines severe enough to require bed rest, liver disease, or a history of stomach problems such as heartburn should also be encouraged to discuss their condition with a healthcare provider. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking a diuretic should be advised to consult a doctor prior to use.

Patients should be reminded to inform their healthcare provider or pharmacist if they are taking any prescription medications for anticoagulation, diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition. It is also important for patients to disclose if they are taking any other drugs or products that contain aspirin, acetaminophen, or any other pain reliever or fever reducer.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is two tablets every six hours, with a maximum of eight tablets within a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

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 Tylo Migraine (acetaminophen), including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)