Excinol Migraine (acetaminophen)

Description

Excinol Migraine is a pharmaceutical formulation containing Acetaminophen as the active ingredient. Each dosage unit delivers 250 mg of Acetaminophen. This medication is indicated for the relief of mild to moderate pain, including headaches associated with migraines.

Uses and Indications

This drug is indicated for the relief of migraine.

There are no teratogenic or nonteratogenic effects mentioned associated with the use of this drug.

Dosage and Administration

Patients are advised to take the medication with a full glass of water for optimal efficacy.

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

For children under 12 years of age, it is essential to consult a healthcare professional 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 drug 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

Patients should be informed of the following warnings and precautions associated with the use of this product.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Allergy Alert Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is required if any signs of an allergic reaction occur.

Liver Warning This product contains acetaminophen, and severe liver damage may result from exceeding the maximum recommended dosage of 8 tablets within a 24-hour period, using it concurrently with other acetaminophen-containing medications, or consuming three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage of the product.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients should limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Discontinuation and Consultation Patients should discontinue use and contact a healthcare provider if they experience any 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 their migraine is not alleviated or worsens after the first dose, if new or unexpected symptoms arise, or if they experience ringing in the ears or hearing loss.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center. Prompt medical intervention is essential for both adults and children, even if no signs or symptoms are initially apparent.

No specific laboratory tests are recommended for monitoring the use of this product.

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 essential to consult a doctor, as these may be early signs of Reye’s syndrome.

Severe allergic reactions 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 acetaminophen-containing products, 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 vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common Adverse Reactions Patients may also experience less severe but notable 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, symptoms indicative of 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 have experienced the worst headache of their life. Other conditions that warrant consultation include fever and stiff neck, headaches following head injury or exertion, daily headaches, severe migraines requiring bed rest, liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma.

Patients should also inform their doctor or pharmacist if they are taking prescription medications for anticoagulation, diabetes, gout, arthritis, or any other serious condition, or if they are using any other products containing aspirin, acetaminophen, or other pain relievers/fever reducers.

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 use of multiple acetaminophen-containing products to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications significantly increases the likelihood of severe gastrointestinal bleeding. Close monitoring for signs of bleeding is recommended in patients receiving these combinations.

Additionally, the use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, alongside this product may elevate the risk of stomach bleeding. Caution is warranted, and patients should be advised to limit the use of NSAIDs while on this medication.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages during treatment with this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, insomnia, and, in some cases, rapid heart rate. Monitoring for these symptoms is recommended to ensure patient safety.

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

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and over are directed to take two tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing this medication to geriatric patients.

Additionally, caution is advised regarding liver health in elderly patients. Severe liver damage may occur if the maximum daily dosage of 8 tablets is exceeded within a 24-hour period. This risk is further amplified when the medication is taken in conjunction with other products containing acetaminophen or when the patient consumes three or more alcoholic beverages daily.

Healthcare providers should ensure that elderly patients are adequately informed about these risks and should consider appropriate dose adjustments and monitoring strategies to mitigate potential adverse effects.

Pregnancy

Pregnant patients or those who are breastfeeding should be advised to consult their healthcare provider regarding the use of this medication. The potential risks and benefits must be carefully considered in these populations. It is essential to evaluate the necessity of treatment against any possible adverse effects on fetal outcomes or breastfeeding infants. Healthcare professionals should remain vigilant in monitoring for any complications that may arise during pregnancy or 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

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 heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential to minimize the potential for adverse effects in this population. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

Overdosage of this product can lead to significant health risks, particularly severe liver damage. Healthcare professionals should be aware of the following critical points regarding overdosage.

Risk Factors for Severe Liver Damage

Severe liver damage may occur if the maximum recommended dosage of 8 tablets within a 24-hour period is exceeded. It is essential for healthcare providers to monitor patients for adherence to this dosage limit to prevent potential complications.

Additionally, the risk of severe liver damage is heightened when this product is taken concurrently with other medications that contain acetaminophen. Healthcare professionals should evaluate a patient's medication regimen carefully to avoid the combined effects of acetaminophen from multiple sources.

Furthermore, the consumption of three or more alcoholic drinks daily while using this product significantly increases the risk of liver damage. It is advisable for healthcare providers to counsel patients on the dangers of alcohol consumption during treatment.

Recommended Actions

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should assess the patient's condition and consider appropriate management strategies, which may include supportive care and monitoring of liver function. Prompt intervention is crucial to mitigate the risk of severe liver injury.

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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, severe liver damage has been associated with the use of acetaminophen, particularly when the maximum daily dosage is exceeded or when used in conjunction with other acetaminophen-containing products or alcohol.

Severe stomach bleeding has also been reported, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, new or unexpected symptoms have been noted, including tinnitus (ringing in the ears) and loss of hearing.

Reports of adverse reactions should be communicated to the appropriate medical authorities for further evaluation and monitoring.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is crucial for both adults and children. It is essential to emphasize that even in the absence of noticeable signs or symptoms, an overdose can still pose serious health risks, and timely intervention is vital.

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

View product document (PDF)