Good Sense Ibuprofen

Description

GOODSENSE® Ibuprofen Liquid Gels are formulated as solubilized ibuprofen capsules, each containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. The product is presented in a smaller capsule size, maintaining the same strength as standard formulations. Each package contains 160 liquid-filled capsules, designed for ease of swallowing. This formulation is comparable to the active ingredient found in Advil® Liqui-Gels® minis.

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, the total dosage must not 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 such reactions 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 taking anticoagulants or steroid medications, are using 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. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

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 symptoms suggestive of stomach bleeding, such as feeling faint, vomiting blood, passing 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 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 using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the 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. This risk is particularly pronounced in patients who use the medication in excess of the recommended dosage 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, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important to discuss use with a doctor if the stomach bleeding warning applies, if there have been serious side effects from pain relievers or fever reducers, or if the patient is taking a diuretic. Additionally, patients under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke should seek advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Co-administration of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the therapeutic efficacy of aspirin. This interaction is clinically significant and warrants careful consideration when prescribing these medications concurrently.

Ibuprofen has the potential to elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Healthcare providers should assess patient history for aspirin allergies prior to initiating ibuprofen therapy.

The concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen, should be approached with caution. Patients are advised to engage in a discussion with their healthcare provider or pharmacist regarding the use of multiple NSAIDs to mitigate the risk of adverse effects.

Patients who are on anticoagulant therapy or corticosteroids should seek medical advice before using ibuprofen, as these medications may increase the risk of bleeding or other complications.

Additionally, individuals taking diuretics are encouraged to consult their healthcare provider prior to initiating ibuprofen, as this combination may necessitate monitoring for potential interactions.

Lastly, patients under medical supervision for serious health conditions should also discuss the use of ibuprofen with their healthcare provider to ensure safe and effective management of their treatment regimen.

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. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, defined as those aged 60 years or older, should exercise caution when using this product due to an increased risk of adverse effects. Special considerations are warranted for geriatric patients with a history of stomach ulcers or bleeding problems, as these conditions may be exacerbated by the use of this medication.

Patients who are concurrently taking blood thinners (anticoagulants) or steroid drugs, as well as those using other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen, should be closely monitored for potential interactions and increased risk of gastrointestinal bleeding. Additionally, elderly patients who consume three or more alcoholic drinks daily while using this product may face heightened risks and should be advised to limit alcohol intake.

It is crucial for geriatric patients to adhere strictly to the recommended dosage and duration of use. Those who take more than directed or for an extended period may experience serious side effects. A history of allergic reactions to pain relievers or fever reducers should also be taken into account, as this may indicate a higher likelihood of adverse reactions.

Elderly patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be evaluated carefully before initiating treatment. The use of this product is contraindicated in patients undergoing heart surgery or those with a known stomach bleeding warning.

Furthermore, patients under a physician's care for any serious condition or those taking diuretics should be monitored closely. It is important to note that ibuprofen may diminish the cardioprotective effects of aspirin when taken for the prevention of heart attacks or strokes, necessitating careful consideration of treatment regimens in this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of ibuprofen is contraindicated after 20 weeks of gestation 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 healthcare professional before using this medication. It is particularly important to avoid the use of 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. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

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 may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects due to impaired drug metabolism. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Patients with significant hepatic impairment should be approached with caution, and the potential benefits of treatment must be weighed against the risks associated with compromised liver function. It is advisable to consider alternative therapies in this population when appropriate.

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 range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. It is crucial for healthcare providers to recognize these signs promptly to ensure appropriate intervention.

Recommended Actions In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center for guidance on managing the situation effectively. Timely intervention can mitigate the risks associated with ibuprofen overdosage and improve patient outcomes.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. This risk is particularly pronounced in patients using higher doses or utilizing these medications for extended durations beyond the recommended guidelines.

Patient Counseling

Healthcare providers should advise patients to take the medication with food or milk if they experience any stomach upset. This guidance is important to help minimize gastrointestinal discomfort and enhance tolerability of the treatment. It is essential for patients to understand the significance of this instruction to ensure optimal use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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), to maintain product integrity. Proper container requirements should be adhered to, ensuring that the product is kept in an appropriate environment to prevent degradation. Special handling needs should be observed to ensure the product remains within the specified temperature range throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

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)