Migraine Relief

Description

Acetaminophen/Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) formulated in the form of caffeine tablets. Each package contains 100 coated caplets, which are designed in a capsule shape for ease of ingestion.

Uses and Indications

This drug is indicated for the treatment of migraine.

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

Dosage and Administration

Adults are instructed to take 2 caplets with a full glass of water. It is essential not to exceed the recommended dosage of 2 caplets within a 24-hour period unless otherwise directed by a healthcare professional.

For individuals under 18 years of age, it is advised to consult a doctor prior to use. If symptoms persist or worsen, patients should seek medical advice.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another 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 this rare but serious condition.

Allergy Alerts Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the use of this product must be discontinued immediately, and medical assistance should be sought without delay.

Aspirin, another ingredient, may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms manifest.

Liver Warning This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding the maximum daily dosage of 2 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), it may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals who are 60 years 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 this product.

Medication Overuse Headache Warning Prolonged use of this product, specifically for 10 or more days per month, may exacerbate headache symptoms.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard 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.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation of Use Healthcare professionals should advise patients to stop using this product and seek medical advice if any of the following occur: an allergic reaction, signs 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 can be serious.

Serious Adverse Reactions:

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to acetaminophen or aspirin. Symptoms of a severe allergic reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms develop, patients should stop using the product and seek immediate medical attention. Similarly, aspirin may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock.

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed the maximum daily dosage of 2 caplets, use other products containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), may also lead to severe stomach bleeding. The risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals 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 experience headaches that worsen with prolonged use of this product, particularly if used for 10 or more days per month, a condition known as medication overuse headache.

Caffeine, present in the recommended dose of this product, may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages while using this product.

Patients should be instructed to stop use and consult a doctor if they experience any new or unexpected symptoms, including ringing in the ears or loss of hearing, or if their migraine is not relieved or worsens after the first dose.

Precautions:

Before using this product, patients should consult a doctor if they have never had migraines diagnosed by a healthcare professional, have a headache that differs from their usual migraines, or have the worst headache of their life. Additional caution is advised for patients with fever and stiff neck, headaches following head injury, or those who are over 50 years old experiencing their first headache.

Patients with liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, patients taking diuretics, those with asthma, or individuals who have experienced serious side effects from pain relievers or fever reducers should consult a healthcare professional before using this product.

Drug Interactions

The concomitant use of caffeine-containing medications, foods, or beverages should be limited while taking this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to consult a healthcare professional prior to using this product if they are currently taking anticoagulants or steroid medications. Additionally, it is recommended that individuals seek medical advice before using this product if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, or naproxen.

Furthermore, patients should engage with a healthcare provider or pharmacist before using this product if they are taking any other medications or products that contain aspirin, acetaminophen, or any other pain reliever or fever reducer. This precaution is essential to avoid potential drug interactions and ensure safe use.

Packaging & NDC

Below are the non-prescription pack sizes of Migraine Relief (acetaminophen, aspirin, caffeine). 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, a rare but serious illness. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these may be early signs of Reye’s syndrome.

For individuals under 18 years of age, it is advised to seek medical guidance before use. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both children and adults, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients, specifically those aged 60 years and older, should consult a healthcare provider prior to using this medication. This precaution is essential to ensure the safe and effective use of the treatment in this population, as age-related physiological changes may influence drug metabolism and response. Careful consideration and monitoring are advised when prescribing to geriatric patients to mitigate potential risks and optimize therapeutic outcomes.

Pregnancy

Pregnant patients and women who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, aspirin should only be used in this period if explicitly directed by a healthcare provider. Caution is advised to ensure the safety of both the mother and the unborn child.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. 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 considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 2 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with known liver disease, including liver cirrhosis, should consult a healthcare professional. Furthermore, individuals with high blood pressure, heart disease, or kidney disease should also seek medical advice prior to use. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. 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 severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Instances of allergic reactions have been documented, necessitating immediate medical attention. Additionally, signs indicative of stomach bleeding have been reported, including feelings of faintness, vomiting of blood, presence of bloody or black stools, and persistent stomach pain.

Reports also indicate that some patients may experience migraines that are not alleviated or may worsen following the initial dose. Furthermore, new or unexpected symptoms have been observed in certain cases. There have been occurrences of tinnitus or hearing loss reported as well.

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 at 1-800-222-1222 without delay. It is crucial to emphasize that quick medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for proper handling and storage. It is recommended to store the product at a temperature range of 20°-25°C (68°-77°F) to maintain its efficacy.

After each use, it is crucial to close the cap tightly to prevent contamination and ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for future reference, as it contains important information regarding the product.

Additional Clinical Information

Patients should take 2 caplets with a glass of water, ensuring not to exceed this dosage within a 24-hour period unless directed by a healthcare professional. For individuals under 18 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding, particularly regarding the use of aspirin after 20 weeks of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is vital for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

This file contains official product information for Migraine Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)