Good Sense Migraine Formula

Description

GOOD SENSE® is a migraine treatment formulated as a combination of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. This product is designed to provide effective pain relief for migraine sufferers. Each package contains 100 coated caplets, which are capsule-shaped tablets. The formulation is comparable to the active ingredients found in Excedrin® Migraine, offering a similar therapeutic effect.

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. 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 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 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 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 may be serious.

Warnings include the risk of Reye’s syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should consult a doctor immediately, as these may be early signs of this rare but serious illness.

Severe skin reactions have been associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Aspirin, another component of this product, may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

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. Additionally, the presence of an NSAID in the formulation 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 anticoagulants, steroids, or other NSAIDs. Patients who consume three or more alcoholic drinks daily or take the medication for longer than directed are also at increased risk.

Patients should be aware that headaches may worsen if this product is used for 10 or more days per month, a condition known as medication overuse headache. Furthermore, the recommended dose contains caffeine equivalent to that of a cup of coffee, and patients are advised to limit the intake of other caffeine-containing products to avoid symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients should 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. Additionally, patients should seek medical advice if they experience ringing in the ears or loss of hearing.

Before using this product, patients are encouraged 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. Other conditions that warrant medical consultation include fever and stiff neck, headaches following head injury, exertion, coughing, or bending, 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 with a history of serious side effects from pain relievers or fever reducers, or those experiencing vomiting with their migraine headache, should also seek medical advice prior to use.

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 any other medications. This includes, but is not limited to, anticoagulants or steroid drugs, as well as any products containing aspirin, acetaminophen, or other pain relievers/fever reducers. Monitoring for potential interactions and adjusting dosages may be necessary based on individual circumstances and the specific medications involved.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense 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, 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 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 fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

Lactation

Lactating mothers are advised to consult a healthcare 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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Furthermore, individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use to ensure safe administration and monitoring of their condition. Regular assessment of liver function may be warranted in these patients to mitigate the risk of adverse effects.

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 presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. The potential for serious complications underscores the importance of rapid response in overdose situations.

Management procedures should include a thorough assessment of the patient's condition, monitoring vital signs, and providing supportive care as needed. It is essential to follow established protocols for overdose management, which may involve decontamination, administration of antidotes, or other therapeutic measures based on the specific substance involved.

In summary, timely intervention and adherence to recommended management strategies are vital in addressing overdose cases 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 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 feelings of faintness, vomiting blood, the presence of bloody or black stools, and persistent stomach pain that does not improve.

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 noted in certain cases. Instances of tinnitus or hearing loss have also been observed.

Patient Counseling

Patients should be advised 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.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help without delay. Additionally, patients should be informed to 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.

Patients should be encouraged 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. They should also seek medical advice if they have a fever accompanied by a stiff neck, headaches that begin after or are caused by head injury, exertion, coughing, or bending, or if they experienced their first headache after the age of 50.

Furthermore, patients should be advised to consult a doctor if they have daily headaches, a migraine so severe that it requires bed rest, liver disease, or if the stomach bleeding warning applies to them. A history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also prompt a discussion with a healthcare provider before use.

Patients taking a diuretic, those with asthma, or individuals who have experienced serious side effects from pain relievers or fever reducers should be encouraged to seek medical advice prior to use. If vomiting accompanies their migraine headache, or if they are taking prescription medications for diabetes, gout, arthritis, or are under a doctor’s care for any serious condition, they should consult a doctor or pharmacist before using this medication. Lastly, patients should be reminded to inform their healthcare provider or pharmacist 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. It is particularly crucial to avoid the use of 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.

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, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)