Good Neighbor Pharmacy Migraine Relief

Uses and Indications

This drug is indicated for the treatment of migraine.

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

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 the counsel of a doctor before administration.

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.

Allergy Alerts This product contains acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and 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, another component of this product, 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. Specifically, this risk increases if more than two caplets are taken within a 24-hour period, if the product is used concurrently with other medications containing acetaminophen, or if the individual consumes 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 potential risk for severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. Caution is also advised for individuals using other NSAIDs, whether prescription or over-the-counter, and for those who consume three or more alcoholic drinks daily while using this product. It is crucial to adhere to the recommended dosage and duration of use to mitigate these risks.

Medication Overuse Headache Warning Frequent use of this product, specifically for ten 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. Patients are advised 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, it is critical to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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

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 skin reactions have been reported with acetaminophen use, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should stop using the product and seek medical assistance immediately. Similarly, aspirin may cause severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily amount of 2 caplets is exceeded, if it is taken with other acetaminophen-containing products, or if consumed with three or more alcoholic drinks daily. Additionally, the presence of an NSAID in the formulation increases 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 anticoagulants, steroids, or other NSAIDs. Patients should be cautioned against using the product for more than 10 days per month, as this may lead to medication overuse headaches.

Common Adverse Reactions

Patients may experience nervousness, irritability, sleeplessness, and occasionally rapid heartbeat due to caffeine intake, as the recommended dose contains approximately the same amount of caffeine as a cup of coffee.

Patients are advised to stop use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if a migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms occur, medical advice should be sought. Patients should also report any ringing in the ears or loss of hearing.

Additional Considerations

Before using this product, patients should consult a healthcare professional if they have never had migraines diagnosed, if they experience headaches that differ from their usual migraines, or if they have the worst headache of their life. Other conditions that warrant consultation include fever with a stiff neck, headaches following head injury or exertion, new headaches after age 50, 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 not use this product if they have a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer.

Drug Interactions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following conditions: 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. It is advised that patients adhere strictly to the recommended dosage and avoid combining this product with other acetaminophen-containing medications to mitigate the risk of liver injury.

This product also contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who are concurrently taking anticoagulants or steroid medications, as well as those using other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen. Patients should be monitored closely for signs of gastrointestinal bleeding and may require dosage adjustments or alternative therapies if they are on anticoagulant or steroid regimens.

Before using this product, it is recommended that patients consult with a healthcare professional if they are taking any other medications that contain aspirin, acetaminophen, or any other pain reliever or fever reducer to avoid potential interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important for healthcare professionals to advise that if any changes in behavior accompanied by nausea and vomiting occur during the use of this product, a doctor should be consulted. 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 prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). The risk is further elevated in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently taking anticoagulants or steroid medications, and patients using other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen. Additionally, consumption of three or more alcoholic drinks daily while using this product may exacerbate the risk of gastrointestinal complications.

It is essential for healthcare providers to exercise caution and consider dose modifications for geriatric patients. Monitoring for signs of gastrointestinal bleeding is advised, especially in those who exceed the recommended dosage or duration of use.

Before initiating treatment, healthcare providers should inquire about the presence of comorbid conditions in elderly patients, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these factors may influence the safety and efficacy of the product.

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 fetal development 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 before 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 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, including liver cirrhosis, should consult a healthcare professional. Furthermore, individuals with high blood pressure, heart disease, or kidney disease are also advised to seek medical advice prior to use. Regular monitoring of liver function may be warranted in patients with compromised liver health 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 presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. The potential for serious complications underscores the importance of rapid intervention.

Management of an overdose may involve supportive care and symptomatic treatment, tailored to the specific circumstances of the patient. Continuous monitoring and assessment are recommended to address any emerging symptoms effectively.

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

No postmarketing experience details are provided in the insert.

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 instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help without delay. Additionally, they should stop use and contact a healthcare professional if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if their migraine is not alleviated 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 doctor.

It is important for patients to consult a healthcare provider before using the medication if they have never had migraines diagnosed by a health professional, if they experience a headache that differs from their usual migraines, or if they have the worst headache of their life. Patients 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. Those with daily headaches or migraines severe enough to require bed rest should also consult a doctor prior to use.

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 guidance before using the medication. Additionally, patients taking diuretics, those with asthma, or individuals who have experienced serious side effects from pain relievers or fever reducers should consult a healthcare provider before use. If a patient experiences vomiting with their migraine headache, they should also seek medical advice.

Finally, patients should be encouraged to discuss with their doctor or pharmacist any prescription medications they are taking for diabetes, gout, arthritis, or any serious condition, as well as any other drugs or products containing aspirin, acetaminophen, or other pain relievers/fever reducers, prior to using this medication.

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°-25°C (68°-77°F) to maintain its efficacy.

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 who are pregnant or breastfeeding should consult a healthcare professional before using the medication. It is particularly crucial to avoid aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)