Goodys Migraine Relief

Description

Goody’s MIGRAINE RELIEF is a combination medication formulated to provide relief from migraine pain. Each coated caplet contains acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, which work synergistically to alleviate discomfort. The product is presented in a package containing 100 capsule-shaped tablets, designed for ease of ingestion.

Uses and Indications

This drug is indicated for the acute treatment of migraine in adults. It is intended for use in patients experiencing migraine attacks and should be administered as per the prescribing guidelines.

Dosage and Administration

Adults should take 2 caplets with a full glass of water. The maximum dosage should not exceed 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.

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 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.

Aspirin, a component of this product, may provoke severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention is warranted 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 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.

The presence of an NSAID in this formulation raises the potential for severe stomach bleeding, particularly 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.

Caffeine is also included in the recommended dose, which is comparable to the caffeine content of a cup of coffee. It is advisable to 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.

Healthcare professionals should advise patients to consult a doctor prior to use if they have never had a migraine diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, present with fever and stiff neck, or have headaches that arise after head injury, exertion, coughing, or bending. Additional caution is warranted for individuals over 50 experiencing their first headache, those with daily headaches, severe migraines requiring bed rest, liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics. Patients with asthma or those who have experienced serious side effects from pain relievers or fever reducers should also seek medical advice before use.

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 if no signs or symptoms are initially apparent.

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 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.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

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 not use this product under these circumstances, and if changes in behavior accompanied by nausea and vomiting occur, medical consultation is advised as these may be early signs of Reye’s syndrome.

Aspirin, a component of this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention is necessary if an allergic reaction occurs.

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 products, or consume three or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this formulation raises the risk of severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or consume three or more alcoholic drinks daily. Patients should also be cautious if they take other NSAIDs or exceed the recommended duration of use.

Caffeine, also included in the recommended dose, may lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat if patients consume excessive amounts from other sources.

Patients are advised to stop using the product and seek medical attention if they experience signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), 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 consult a healthcare professional if they have never had migraines diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, have fever and stiff neck, or have headaches that began after a head injury or exertion. Additional caution is warranted for patients with liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or other medications that may interact with this product.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the concurrent use of these agents to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. Close monitoring for signs of bleeding is recommended, and dosage adjustments may be necessary based on clinical judgment.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, may elevate the risk of stomach bleeding. Caution is warranted, and it is recommended to limit or avoid the use of these NSAIDs during treatment.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye’s syndrome. Healthcare professionals should advise that if any changes in behavior accompanied by nausea and vomiting occur while using this product, a doctor should be consulted, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition. For patients under 18 years of age, it is recommended to seek medical advice before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood thinners (anticoagulants) or steroid medications, and patients taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, or naproxen.

Additionally, the risk of stomach bleeding is amplified in geriatric patients who consume three or more alcoholic drinks daily while using this product, or who exceed the recommended dosage or duration of use. Therefore, careful monitoring and consideration of these factors are essential when prescribing this medication to elderly patients. Dose adjustments may be necessary based on individual risk profiles to ensure safety and minimize potential adverse effects.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is particularly concerning, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, 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 while breastfeeding.

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 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 concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Consumption of three or more alcoholic drinks daily while using this product is also contraindicated, as it may exacerbate the potential for liver damage.

Patients with a history of liver disease, liver cirrhosis, high blood pressure, heart disease, or kidney disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these individuals 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 during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to report at this time.

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. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in a package that should be retained for important information. It is essential to store the product at temperatures below 20ºC to 25ºC (68º to 77ºF). Once opened, the product must be discarded to ensure safety and efficacy. Additionally, it is crucial to keep the product out of reach of children. In the event of an overdose, prompt medical attention is necessary for both adults and children.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)