Good Sense Headache Relief

Description

GOODSENSE® Extra Strength is a formulation designed for headache relief, containing a combination of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. This product serves as a pain reliever and pain reliever aid. Each package contains 80 geltabs, providing a convenient dosage form for users. The active ingredients are comparable to those found in Excedrin® Extra Strength, ensuring a similar therapeutic effect.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold symptoms, arthritis, muscular aches, toothache, and premenstrual or menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs within a 24-hour period. It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals 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 illness.

Allergy Alerts

Acetaminophen 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.

Aspirin may also provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms arise.

Liver Warning

This product contains acetaminophen, and severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen 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. The likelihood of this adverse effect increases in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, 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 dosage or duration of use.

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 while using this product, 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 at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

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), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, or the emergence of any new symptoms. These may indicate a serious condition requiring further evaluation.

Side Effects

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

Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. Patients should not use this product if they fall into this category. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these may be early signs of Reye’s syndrome.

Severe skin reactions have been reported in patients taking acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance immediately. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating prompt medical attention.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

Furthermore, the presence of an NSAID in this product 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 blood thinners, steroids, or other NSAIDs. Patients should be cautious if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

Caffeine is also included in the recommended dose, which is comparable to that found in a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additional symptoms warranting medical attention include ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than three days, or the emergence of any new symptoms, as these could indicate a serious condition.

Drug Interactions

The concurrent use of this product with caffeine-containing medications, foods, or beverages should be limited. 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 anticoagulants or steroid medications. Additionally, it is recommended that individuals seek guidance from a doctor or pharmacist if they are using other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, or naproxen.

Furthermore, those on prescription medications for diabetes, gout, or arthritis should also consult a healthcare provider before using this product to ensure safety and efficacy.

It is imperative to avoid the use of this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, patients should seek clarification from a healthcare professional.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Headache 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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, children under 12 years of age should consult a doctor before use. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period.

It is essential to keep this product 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 medical attention is critical for both adults and children, 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 safety and appropriateness of treatment, as geriatric patients may have different physiological responses and potential comorbidities that could influence the medication's effects and safety profile. Careful consideration and monitoring are advised when prescribing this medication to this age group.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and lead to complications during delivery. It is essential for healthcare providers to evaluate the necessity of aspirin in these circumstances and to consider alternative treatments when appropriate.

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 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 degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions. Specifically, patients should be aware that exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

Due to these considerations, careful monitoring of liver function is advised for patients with compromised liver function. Adjustments to dosage or alternative therapies may be necessary based on the severity of hepatic impairment and individual patient circumstances.

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 essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely medical evaluation are crucial in managing overdose situations 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 have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Instances of allergic reactions have been documented, necessitating immediate medical attention. Signs indicative of potential stomach bleeding have also been reported, including faintness, vomiting of blood, presence of bloody or black stools, and persistent stomach pain.

Additionally, cases of tinnitus or hearing loss have been noted. Reports of localized pain have included observations of redness or swelling in the affected area. There have been instances where pain has worsened or persisted beyond 10 days, as well as cases where fever has intensified or lasted more than 3 days. Furthermore, any emergence of new symptoms has been recorded.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

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 temperature range of 20° to 25°C (68° to 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 important information regarding the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional before use. It is particularly important to avoid aspirin use 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. Additionally, patients should be reminded to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)