Migraine Relief

Description

This formulation contains acetaminophen and aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID), along with caffeine. The product is presented in the form of 100 coated caplets, which are capsule-shaped. It is specifically designed for migraine relief and serves as a pain reliever and pain reliever aid. The formulation is free from gluten, ensuring suitability for individuals with gluten sensitivities. This product is comparable to the active ingredients found in Excedrin® Migraine.

Uses and Indications

This drug is indicated for the treatment of migraine. There are no teratogenic or nonteratogenic effects associated with its use.

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.

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 advised to seek a doctor's recommendation before use.

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 other medications, 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 may be early indicators 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 skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought without delay.

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 manifest.

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 disorders, or those taking anticoagulants or steroid medications. The risk is further elevated with the concurrent use of other NSAIDs (including aspirin, ibuprofen, or naproxen) or if the product is taken in excess or for prolonged periods. Alcohol consumption of three or more drinks daily while using this product also increases the risk of stomach bleeding.

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 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 migraines 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 notice changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

Severe skin reactions have been reported with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should stop using the product and seek medical attention immediately. Similarly, aspirin may cause severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock, necessitating immediate medical intervention.

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 within 24 hours, use other medications 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 lead to severe stomach bleeding, especially in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants or other NSAIDs. The risk is further heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

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. Additionally, the product contains caffeine, which may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat if combined with other caffeine-containing substances.

Patients are advised to stop using the product and consult a doctor if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. They should also seek medical advice 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.

Precautions:

Before using this product, patients should consult a healthcare professional if they have never had migraines diagnosed, experience headaches that differ from their usual migraines, or have other specific medical conditions, including liver disease, high blood pressure, or a history of stomach problems. Pregnant or breastfeeding patients should also seek medical advice prior to use, particularly regarding aspirin use after 20 weeks of pregnancy, as it may pose risks to the unborn child or complicate delivery.

Drug Interactions

Concurrent use of this product with other medications containing acetaminophen is contraindicated due to the risk of acetaminophen overdose, which may lead to severe liver damage.

Patients are advised to consult a healthcare professional prior to using this product if they are concurrently taking anticoagulants or steroid medications, as these combinations may increase the risk of adverse effects.

Additionally, caution is warranted when using this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen. Patients should seek medical advice to evaluate the necessity and safety of such combinations.

It is also recommended to limit the intake of caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine may exacerbate potential side effects.

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

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 any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these may be early signs of Reye’s syndrome.

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 a Poison Control Center should be contacted without delay, as prompt medical attention is critical for both children and adults, even if no signs or symptoms are 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 or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider, particularly in the later stages of pregnancy.

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 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 severity 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 alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease or those with conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a healthcare professional. Monitoring of liver function may be warranted in these patients 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 attention 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 procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and intervention may be necessary to address any complications that arise from the overdose.

It is vital to maintain open communication with poison control and other medical professionals throughout the management process to ensure optimal care and outcomes for the patient.

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.

Allergic reactions have been documented, and individuals are advised to seek medical assistance immediately if such reactions occur. Additionally, signs indicative of stomach bleeding have been reported, including faintness, vomiting of blood, presence of bloody or black stools, and persistent stomach pain.

Reports also indicate that some patients may experience unresolved or worsening migraines following the initial dose. Furthermore, new or unexpected symptoms have been noted in certain cases. Instances of tinnitus or hearing loss have also been observed.

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 caution patients against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, 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, if a patient's migraine is not alleviated or worsens after the first dose, or if new or unexpected symptoms arise, they should seek medical advice. Patients should also be made aware that ringing in the ears or loss of hearing warrants immediate consultation.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if they have never had a migraine diagnosed by a health professional, if they experience headaches that differ from their usual migraines, or if they have the worst headache of their life. Patients presenting with fever and a stiff neck, headaches following head injury, exertion, coughing, or bending, or those who experience their first headache after the age of 50 should also be advised to seek medical guidance.

Patients with daily headaches, migraines severe enough to require bed rest, or those with liver disease should be encouraged to discuss their condition with a healthcare provider prior to use. Furthermore, patients should be advised to consult a doctor if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking a diuretic.

Patients with asthma or those who have experienced serious side effects from pain relievers or fever reducers should also be directed to seek medical advice before use. If patients experience vomiting with their migraine headache, they should be encouraged to consult a healthcare professional. Lastly, patients taking prescription medications for diabetes, gout, arthritis, or any serious condition, as well as those taking any other drugs or products containing aspirin, acetaminophen, or other pain relievers or fever reducers, should be advised to consult a doctor or pharmacist prior to use.

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

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)