Migraine Formula

Description

Meijer® Migraine Formula is a pain reliever designed to alleviate migraine symptoms. This formulation contains active ingredients including acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. The product is presented in the form of 24 coated caplets, which are capsule-shaped for ease of ingestion. This formulation is comparable to the active ingredients found in Excedrin® Migraine Relief.

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 advised to take 2 caplets with a full glass of water. It is important not to exceed the recommended dosage of 2 caplets within a 24-hour period unless specifically directed by a healthcare professional. In cases where symptoms persist or worsen, patients should consult their doctor for further evaluation and guidance.

For individuals under 18 years of age, it is recommended to seek advice from a healthcare provider before use.

Contraindications

Use is contraindicated in individuals 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 avoid using 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 This product contains acetaminophen, which has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any of these reactions occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

Additionally, aspirin 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 arise.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage can occur under certain conditions. This includes 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), there is a risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants or steroid medications. The risk is further heightened with the concurrent use of other NSAIDs (including aspirin, ibuprofen, or naproxen), excessive alcohol consumption, or prolonged use beyond the recommended duration.

Medication Overuse Headache Warning Frequent use of this product, defined as 10 or more days per month, may lead to worsening headaches.

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 result in 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 and Consultation Users should stop using the product and consult a healthcare professional 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 a migraine is not alleviated or worsens 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 should be aware of several serious adverse reactions and warnings associated with its use.

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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye’s syndrome.

Severe skin reactions may occur due to acetaminophen, with symptoms including skin reddening, blisters, and rash. If any skin reaction is observed, patients should discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 2 caplets within 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

Furthermore, 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 or other NSAIDs. Patients should also be cautious if they consume three or more alcoholic drinks daily or exceed the recommended duration of use.

Medication overuse headaches may occur if this product is used for 10 or more days per month. Patients should also be aware that the recommended dose contains caffeine equivalent to a cup of coffee, and excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), if their migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, including ringing in the ears or loss of hearing.

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

This product should be kept out of reach of children. In the event of an overdose, immediate medical help or contact with a Poison Control Center is essential, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

The concomitant use of this product with caffeine-containing medications, foods, or beverages should be limited. 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 if they are using other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, or naproxen, whether prescription or over-the-counter.

Furthermore, individuals should consult a healthcare provider if they are taking any other products that contain aspirin, acetaminophen, or any other analgesics or antipyretics.

Patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical consultation before using this product, as these conditions may influence its safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Migraine Formula (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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate an early sign of Reye’s syndrome, a rare but serious condition.

For pediatric patients 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 essential for both adults and children, 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 those 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 the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation 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 may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to the dosing regimen may be necessary based on the degree of renal impairment to avoid potential adverse effects and to optimize therapeutic outcomes.

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.

Prior to use, patients with known liver disease, liver cirrhosis, high blood pressure, heart disease, or kidney disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects associated with acetaminophen.

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 noticeable 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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Severe skin reactions associated with acetaminophen have been noted, which may include symptoms such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, severe allergic reactions related to aspirin have been reported, potentially manifesting as asthma (wheezing) and shock.

Stomach bleeding has been observed, particularly in patients with a history of stomach ulcers or bleeding problems, and the risk may increase when used in conjunction with other NSAIDs. Medication overuse headache has also been documented, with a tendency to worsen if the product is used for 10 or more days per month. Furthermore, new or unexpected symptoms have been reported following use, along with instances of ringing in the ears or loss of hearing.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) 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.

Patients should be informed not to use this medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is essential to avoid concurrent use with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients must be instructed to discontinue use and consult a healthcare professional if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical advice 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 loss of hearing.

Before initiating treatment, patients should be advised to consult a doctor if they have never had migraines diagnosed by a healthcare professional, if they experience headaches that differ from their usual migraines, or if they have the worst headache of their life. They should also seek medical advice if they have a fever accompanied by a stiff neck, if headaches begin after or are caused by head injury, exertion, coughing, or bending, or if they experienced their first headache after the age of 50. Patients with daily headaches or migraines severe enough to require bed rest should also consult a doctor prior to use.

Furthermore, patients with liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to seek medical consultation before using this medication. Those taking diuretics, individuals with asthma, or patients who have experienced serious side effects from pain relievers or fever reducers should also be encouraged to discuss their situation with a healthcare provider.

Patients should be reminded to consult a doctor or pharmacist before use if they are taking any prescription medications for diabetes, gout, arthritis, or if they are under a doctor’s care for any serious condition. It is also important for patients to check with a healthcare professional 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and safety.

After each use, the cap must be closed 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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use, particularly emphasizing the risks associated with aspirin use after 20 weeks of pregnancy, as it may lead to complications for the unborn child or during delivery.

Patients should be instructed to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center (1-800-222-1222), as prompt medical attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)