Good Sense Migraine Formula

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the treatment of migraine. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

Adults should take 2 geltabs with a full glass of water. It is important not to exceed 2 geltabs within a 24-hour period unless otherwise directed by a healthcare professional. For individuals under 18 years of age, dosing should be determined by a physician.

Healthcare professionals are advised to ensure that patients understand the importance of adhering to the recommended dosage and to provide guidance on the appropriate use of this medication.

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 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 arise.

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 geltabs within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages 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 severe 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 at 1-800-222-1222.

Discontinuation and Consultation 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 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 allergic reactions have been reported with the use of acetaminophen and aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should stop use and seek medical help immediately. Aspirin may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

Liver damage is a significant risk associated with this product due to its acetaminophen content. Severe liver damage may occur if patients exceed the maximum daily dosage of 2 geltabs within 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Stomach bleeding is another serious risk, particularly for patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants or other NSAIDs. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common Adverse Reactions:

Patients may also experience medication overuse headaches if this product is used for 10 or more days per month. Additionally, the caffeine content, which is comparable to that of a cup of coffee, may lead to severe nervousness, irritability, sleeplessness, and occasionally rapid heartbeat if combined with other caffeine-containing substances.

Patients are advised to stop use and consult a doctor if they experience any allergic reactions, worsening migraines after the first dose, new or unexpected symptoms, or symptoms such as 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.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

For individuals under 18 years of age, medical advice should be sought prior to use. Quick medical attention is critical for both children and adults, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this product. Caution is advised in this population, and healthcare providers should monitor for signs of gastrointestinal bleeding.

This product contains acetaminophen, and it is important to note that severe liver damage may occur if more than 2 geltabs are taken within a 24-hour period, which is the maximum recommended daily dosage. Geriatric patients should be advised to adhere strictly to this dosage limit to minimize the risk of liver injury.

Before initiating treatment, healthcare providers should inquire about any pre-existing conditions in elderly patients, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these may necessitate further evaluation or adjustments in therapy. Additionally, a history of stomach problems, such as heartburn, should be discussed prior to use.

Elderly patients are also at risk for medication overuse headaches, which may worsen if this product is used for 10 or more days per month. Monitoring for headache frequency and severity is recommended to prevent potential complications associated with prolonged use.

Pregnancy

Pregnant patients and women 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, aspirin should only be used in this period if explicitly directed by a healthcare provider. Caution is advised to ensure the safety of both the mother and the unborn child.

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, 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 mitigate the risk of adverse effects and 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 geltabs 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 liver disease or any history of liver impairment should consult a healthcare professional. This recommendation also extends to individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these conditions may further complicate the safe use of this product. Regular monitoring of liver function may be warranted in patients with compromised liver health 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 intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant, as the clinical presentation of an overdose may not be immediately apparent. Therefore, timely evaluation and management are essential to mitigate potential risks associated with overdose situations.

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 reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Severe skin reactions have also been noted, characterized by skin reddening, blisters, and rash.

Additionally, instances of severe liver damage have been reported, particularly in cases of overdose or concurrent use with other acetaminophen-containing products. Severe stomach bleeding has been observed, especially in individuals over 60 years of age or those with a history of stomach ulcers or bleeding problems.

Medication overuse headache may occur if the product is used for 10 or more days per month. New or unexpected symptoms have been documented, including ringing in the ears or loss of hearing. Symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, have also been reported.

It is emphasized that quick medical attention is critical for both adults and children in the event of an overdose, even if no signs or symptoms are present.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, they should be cautioned against using this medication in conjunction with any other drug 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 stop using the medication and consult a doctor 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. They should also be advised to seek medical attention if their migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise. Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears or loss of hearing.

Before using this medication, patients should be encouraged to consult a doctor if they have never had migraines diagnosed by a healthcare professional, if they have a headache that differs from their usual migraines, or if they are experiencing 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.

Additionally, 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 advice 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 consult a doctor. Patients experiencing vomiting with a migraine headache should be encouraged to seek medical advice.

Finally, patients should be instructed to consult a doctor or pharmacist before using this medication if they are taking any prescription drugs for diabetes, gout, or arthritis, if they are under a doctor’s care for any serious condition, or if they are taking any other medications 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 are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature of 20°-25°C (68°-77°F) to ensure its stability and efficacy.

After each use, it is crucial to close the cap tightly to maintain the integrity of the product and prevent contamination. Proper handling and storage conditions are vital for preserving the quality of the product throughout its shelf life.

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 the use of aspirin at 20 weeks of gestation or later unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

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)