Good Sense Ibuprofen

Description

GOODSENSE® Ibuprofen Liquid Gels contain solubilized ibuprofen in a dosage form of liquid-filled capsules, each delivering 200 mg of ibuprofen. This nonsteroidal anti-inflammatory drug (NSAID) is indicated for the relief of pain and reduction of fever. The product is designed for comparison with the active ingredient found in Advil® Liqui-Gels®. Each package contains 40 liquid gels, providing a convenient option for dosing.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative not to exceed 6 capsules within a 24-hour period unless otherwise directed by a healthcare professional.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek emergency medical assistance.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened with the use of higher doses or prolonged treatment.

Healthcare professionals should advise patients to seek immediate medical attention if they experience any signs of an allergic reaction. Furthermore, patients should be instructed to discontinue use and consult a physician if they exhibit any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation.

Patients should be advised to stop using ibuprofen and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if there is redness or swelling in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential to ensure patient safety during ibuprofen therapy.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen carries a significant risk of severe stomach bleeding, especially in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, or are concurrently taking anticoagulants or steroid medications. The risk is further heightened in those who consume three or more alcoholic drinks daily while using this product or who exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, have been associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in higher doses or for extended periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach bleeding, serious side effects from pain relievers or fever reducers, or any underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that patients inform their healthcare provider if they are taking diuretics or if they are under medical care for any serious condition. Additionally, those taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The use of ibuprofen is associated with several important drug interactions and considerations that healthcare professionals should be aware of.

Interactions with Anticoagulants and Other NSAIDs Ibuprofen may diminish the antiplatelet effect of aspirin when both are used concurrently for cardiovascular protection. Therefore, patients should be advised to avoid the simultaneous use of ibuprofen and aspirin for heart attack or stroke prevention. Additionally, ibuprofen can interact with other anticoagulant medications, necessitating careful monitoring of patients on these therapies to mitigate the risk of bleeding.

Interactions with Other NSAIDs Concurrent use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as naproxen, is not recommended due to the potential for increased adverse effects, particularly gastrointestinal complications.

Considerations for Patients on Diuretics Patients taking diuretics should consult their healthcare provider prior to initiating ibuprofen therapy, as this combination may lead to reduced diuretic efficacy and potential fluid retention.

Cautions in Specific Populations The use of ibuprofen is cautioned against in individuals with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. These patients should be closely monitored, and alternative therapies may be considered.

Alcohol Consumption Patients are advised to limit alcohol intake to fewer than three drinks per day while using ibuprofen, as higher consumption may significantly increase the risk of gastrointestinal bleeding.

History of Gastrointestinal Issues Individuals with a history of gastrointestinal problems, such as heartburn or peptic ulcers, should consult their healthcare provider before using ibuprofen to assess the risk of exacerbating these conditions.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules in a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, defined as those aged 60 years or older, should be closely monitored when using this product due to an increased risk of adverse effects. Special caution is warranted for geriatric patients with a history of stomach ulcers or bleeding problems, as the risk of gastrointestinal bleeding is heightened.

Patients who are concurrently taking anticoagulants or steroid medications, as well as those using other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen, should be advised of the potential for increased bleeding risk. Additionally, elderly patients consuming three or more alcoholic drinks daily while using this product may experience exacerbated side effects and should be counseled accordingly.

It is crucial for geriatric patients to adhere to the recommended dosage and duration of use. Taking more than directed or for an extended period can lead to serious complications. Those with a history of allergic reactions to pain relievers or fever reducers should avoid this product.

Elderly patients who have undergone heart surgery should refrain from using this product immediately before or after the procedure. Furthermore, individuals with a history of stomach problems, such as heartburn, or those with comorbidities including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should exercise caution.

Patients on diuretics or under a physician's care for any serious medical condition should consult their healthcare provider prior to use. It is also important to note that ibuprofen may diminish the cardioprotective effects of aspirin when taken for the prevention of heart attack or stroke. Therefore, careful consideration and monitoring are essential for geriatric patients using this product.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against any risks when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function and any potential risks associated with the medication. Monitoring of liver function may be necessary to ensure safety and efficacy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the overall health status of patients with compromised liver function before initiating therapy.

Overdosage

Overdosage of ibuprofen can lead to significant health risks and serious harm. Healthcare professionals should be aware of the potential symptoms and recommended actions in the event of an overdose.

Symptoms of Overdose

Patients experiencing an ibuprofen overdose may present with a variety of symptoms. Common manifestations include:

• Nausea

• Vomiting

• Stomach pain

• Drowsiness

• Headache

• Confusion

These symptoms can vary in severity and may require prompt medical evaluation.

Recommended Actions

In the event of an ibuprofen overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance. Timely intervention is essential to mitigate the potential adverse effects associated with ibuprofen overdosage.

Nonclinical Toxicology

It is especially important not to use ibuprofen 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. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the product if they have a history of allergic reactions to any other pain reliever or fever reducer. It is crucial to instruct patients to avoid using the medication right before or after heart surgery.

Patients should be made aware of the signs of potential stomach bleeding and instructed to stop use and consult a doctor if they experience any of the following: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, patients should be cautioned to seek medical advice if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Healthcare providers should emphasize that patients must stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts more than 3 days. Patients should also be advised to seek medical attention if they notice redness or swelling in the painful area or if any new symptoms arise.

When using this product, patients should be instructed to take it with food or milk if they experience stomach upset. It is important for healthcare providers to recommend that patients consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics or any other medications should be advised to consult a doctor or pharmacist before use. It is also essential to inform patients that if they are under a doctor's care for any serious condition or are taking aspirin for heart attack or stroke, they should seek advice from a healthcare professional, as ibuprofen may reduce the effectiveness of aspirin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of 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 1 capsule every 4 to 6 hours as needed for symptom relief. If symptoms persist and do not respond to 1 capsule, 2 capsules may be taken; however, the total should not exceed 6 capsules in a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is advised.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a healthcare professional before use. It is particularly important to avoid ibuprofen during the last trimester 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 keep the medication out of reach of children and be aware that in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Information (PDF)

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

View product document (PDF)