Ibuprofen

Description

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen appears as a white powder with a melting point of 74-77° C. It is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The tablets are available in strengths of 400 mg, 600 mg, and 800 mg for oral administration. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, and titanium dioxide.

Uses and Indications

Ibuprofen tablets are indicated for the relief of the signs and symptoms associated with rheumatoid arthritis and osteoarthritis. Additionally, these tablets are indicated for the relief of mild to moderate pain and for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in pediatric populations have not been conducted. Therefore, healthcare professionals should exercise caution when considering the use of ibuprofen in children.

Dosage and Administration

Healthcare professionals should carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before initiating therapy. It is recommended to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After assessing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to meet the specific needs of the patient. The total daily dose should not exceed 3200 mg. In cases where gastrointestinal complaints arise, ibuprofen tablets should be administered with meals or milk to mitigate discomfort.

For the management of rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease, the suggested dosage ranges from 1200 mg to 3200 mg daily. This can be achieved through various dosing regimens, such as 300 mg four times a day, or 400 mg, 600 mg, or 800 mg three to four times a day. The dosage should be tailored to each patient, with adjustments made based on the severity of symptoms at the initiation of therapy or in response to treatment. It is noted that patients with rheumatoid arthritis may require higher doses compared to those with osteoarthritis. The smallest effective dose that provides acceptable control should be utilized.

In chronic conditions, a therapeutic response to ibuprofen tablets may be observed within a few days to a week, but is most commonly noted by two weeks. Once a satisfactory response is achieved, the patient's dosage should be reviewed and adjusted as necessary.

For the treatment of mild to moderate pain, ibuprofen tablets may be administered at a dose of 400 mg every 4 to 6 hours as needed for pain relief. In the case of dysmenorrhea, treatment should commence at the earliest onset of pain, with ibuprofen tablets given at a dose of 400 mg every 4 hours as necessary for relief.

Contraindications

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. They should not be administered to individuals who have experienced asthma, urticaria, or allergic-type reactions following the use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), as severe, potentially fatal, anaphylactic-like reactions have been reported in these patients. Additionally, the use of ibuprofen tablets is contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Caution is advised when considering ibuprofen for patients with preexisting asthma, particularly those with aspirin-sensitive asthma.

Warnings and Precautions

Non-steroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Tablets, are associated with an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may manifest early in treatment and is likely to escalate with prolonged use. Ibuprofen Tablets are contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.

The use of NSAIDs is also linked to a heightened risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during treatment and may present without warning symptoms. Elderly patients are particularly vulnerable to these serious gastrointestinal complications. Patients with known cardiovascular disease or risk factors exhibit a higher absolute incidence of serious cardiovascular thrombotic events. Therefore, the use of Ibuprofen Tablets should be avoided in patients with a recent myocardial infarction unless the anticipated benefits outweigh the risks of recurrent cardiovascular thrombotic events.

NSAIDs can contribute to the onset of new hypertension or exacerbate preexisting hypertension. Long-term administration of NSAIDs has been associated with renal complications, including renal papillary necrosis and other forms of renal injury. Anaphylactoid reactions may occur in patients without prior exposure to ibuprofen; in such cases, emergency medical assistance should be sought immediately. Serious skin adverse events, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported and can be fatal. Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been documented in patients taking NSAIDs, including ibuprofen, with some cases being fatal or life-threatening. The use of NSAIDs in pregnant women at approximately 30 weeks gestation and later should be avoided due to the risk of premature closure of the fetal ductus arteriosus.

Ibuprofen Tablets are not a substitute for corticosteroids and should not be used to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of the underlying condition. For patients on prolonged corticosteroid therapy, a gradual tapering of the corticosteroid dosage is recommended if discontinuation is necessary. Patients exhibiting symptoms or signs of liver dysfunction, or those with abnormal liver test results, should be evaluated for potential severe hepatic reactions while on ibuprofen therapy. Careful monitoring is advised for patients receiving ibuprofen who may be adversely affected by changes in platelet function. Additionally, patients with asthma who have aspirin-sensitive asthma should not be administered ibuprofen.

Physicians should monitor patients on long-term NSAID treatment for signs or symptoms of gastrointestinal bleeding. Regular checks of complete blood count (CBC) and chemistry profiles are recommended for these patients. If clinical signs and symptoms indicative of liver or renal disease develop, or if abnormal liver tests persist or worsen, ibuprofen should be discontinued.

Emergency medical help should be sought in cases of anaphylactoid reactions. Patients are advised to discontinue ibuprofen at the first sign of a skin rash or any other indication of hypersensitivity. If symptoms consistent with liver disease or systemic manifestations such as eosinophilia or rash occur, ibuprofen should be stopped. Furthermore, if signs or symptoms of meningitis develop in a patient taking ibuprofen, the possibility of a connection to the medication should be considered.

Side Effects

Patients may experience a range of adverse reactions while using the medication, categorized by seriousness and frequency.

Gastrointestinal adverse reactions are common and may include nausea, epigastric pain, heartburn, diarrhea, abdominal distress, vomiting, indigestion, constipation, abdominal cramps, and bloating. Serious gastrointestinal events, although less frequent, can occur, such as gastric or duodenal ulcers with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, and pancreatitis. Notably, borderline elevations of liver function tests may occur in up to 15% of patients, with significant elevations reported in approximately 1% of clinical trial participants.

Central nervous system effects are also observed, with dizziness, headache, and nervousness being common. More serious reactions, though rare, include depression, insomnia, confusion, emotional liability, somnolence, and aseptic meningitis, which can present with fever and coma. Other reported symptoms include paresthesias, hallucinations, and dream abnormalities.

Dermatologic reactions can range from mild to severe, with common manifestations including rash and pruritus. Serious skin reactions such as vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Photoallergic skin reactions may also occur.

Hematologic adverse reactions include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), and thrombocytopenia, with or without purpura. Patients may also experience bleeding episodes, such as epistaxis and menorrhagia.

Metabolic and endocrine reactions may manifest as decreased appetite, gynecomastia, hypoglycemic reactions, and acidosis. Cardiovascular effects include edema and fluid retention, which generally respond promptly to drug discontinuation. Serious cardiovascular events such as congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, and arrhythmias (including sinus tachycardia and bradycardia) have also been reported.

Allergic reactions can range from mild to severe, including a syndrome characterized by abdominal pain, fever, chills, nausea, and vomiting, as well as anaphylaxis and bronchospasm. Other allergic conditions such as serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, and angioedema have been noted.

Renal adverse reactions may include acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria, and renal papillary necrosis. Miscellaneous reactions reported include dry eyes and mouth, gingival ulcer, and rhinitis.

It is important to note that aseptic meningitis with fever and coma has been observed in rare cases among patients undergoing ibuprofen therapy. Additionally, anaphylactoid reactions may occur in patients without prior exposure to ibuprofen, and the medication should not be administered to individuals with the aspirin triad.

Drug Interactions

Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and various other medications may lead to significant drug interactions that require careful consideration.

Antihypertensive Agents NSAIDs may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors when used together. It is advisable to monitor blood pressure closely in patients receiving this combination.

Antiplatelet Agents Ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered prior to aspirin. This interaction may increase the risk of cardiovascular events; therefore, alternative analgesics should be considered for patients on low-dose aspirin therapy.

Diuretics The use of ibuprofen may reduce the natriuretic effect of furosemide and thiazide diuretics. Close observation for signs of renal failure is recommended during concomitant therapy.

Lithium Ibuprofen has been shown to elevate plasma lithium levels and reduce renal clearance of lithium, which increases the risk of lithium toxicity. Monitoring of lithium levels is advised when these medications are used together.

Methotrexate NSAIDs may enhance the toxicity of methotrexate. Caution is warranted when these agents are administered concomitantly, and patients should be monitored for signs of toxicity.

Anticoagulants Caution is also advised when administering ibuprofen to patients on warfarin-type anticoagulants due to an increased risk of serious gastrointestinal bleeding. Regular monitoring of coagulation parameters is recommended.

Gastrointestinal Agents Co-administration of cimetidine or ranitidine with ibuprofen does not appear to have a substantive effect on ibuprofen serum concentrations, and no dosage adjustments are necessary in this context.

Packaging & NDC

The table below lists all NDC Code configurations of Ibuprofen, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established. Therefore, caution should be exercised when considering the use of ibuprofen in this population. Further studies are needed to determine appropriate dosing and outcomes in children.

Geriatric Use

Caution should be exercised when treating elderly patients (65 years and older) with this medication, as with any nonsteroidal anti-inflammatory drugs (NSAIDs). It is important for healthcare providers to consider the increased risk of adverse effects in this population. Monitoring for potential side effects and adjusting dosages as necessary may be warranted to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy is associated with significant risks, particularly when used in the later stages of gestation. Administration of NSAIDs around 30 weeks of gestation or later can lead to premature closure of the fetal ductus arteriosus, a critical vessel in fetal circulation. This risk necessitates avoiding NSAID use in this timeframe.

Additionally, the use of NSAIDs from approximately 20 weeks of gestation onward has been linked to fetal renal dysfunction, which can result in oligohydramnios and, in some instances, neonatal renal impairment. These adverse outcomes may manifest after days to weeks of treatment, although oligohydramnios has been reported as early as 48 hours following initiation of NSAID therapy. In cases where NSAID treatment extends beyond 48 hours, monitoring with ultrasound for oligohydramnios is recommended. If oligohydramnios is detected, discontinuation of ibuprofen tablets should be considered, followed by appropriate clinical follow-up.

Animal studies have demonstrated that prostaglandin synthesis inhibitors, such as ibuprofen, can lead to increased pre- and post-implantation loss and may impair kidney development at clinically relevant doses. While observational studies have provided inconclusive data regarding other potential embryo-fetal risks associated with NSAID use during the first and second trimesters, there are no adequate and well-controlled studies in pregnant women. Therefore, ibuprofen should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.

Healthcare professionals are advised to limit the dose and duration of ibuprofen tablets use between approximately 20 and 30 weeks of gestation and to avoid use at or beyond 30 weeks of gestation. Caution is warranted due to the potential for serious adverse fetal outcomes, including irreversible neonatal renal dysfunction, which may require invasive interventions such as exchange transfusion or dialysis. The methodological limitations of existing postmarketing studies, including the absence of control groups and insufficient data on dosage and timing, hinder the ability to establish a reliable risk estimate for adverse fetal and neonatal outcomes associated with maternal NSAID use.

Lactation

It is not known whether this drug is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from ibuprofen tablets, lactating mothers should consider the importance of the drug to their health when making a decision to either discontinue nursing or discontinue the drug.

Renal Impairment

Long-term administration of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury. In patients with reduced kidney function, renal prostaglandins play a compensatory role in maintaining renal perfusion. The use of NSAIDs may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and precipitate overt renal decompensation.

Patients at greatest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, individuals taking diuretics and ACE inhibitors, and the elderly. In cases where NSAID therapy is initiated, close monitoring of renal function is advisable. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state.

There is no available information from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease; therefore, treatment with ibuprofen tablets is not recommended in this population. If ibuprofen tablet therapy is deemed necessary, it should be approached with caution, and renal function should be closely monitored.

Additionally, the use of NSAIDs, including ibuprofen tablets, during pregnancy, particularly around 20 weeks gestation or later, may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes may occur after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours after initiation. If NSAID treatment is required between 20 and 30 weeks of gestation, it is recommended to limit ibuprofen tablets to the lowest effective dose and shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if treatment extends beyond 48 hours, and ibuprofen tablets should be discontinued if oligohydramnios occurs, with follow-up according to clinical practice.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics and increased risk of adverse effects when treated with NSAIDs. Long-term administration of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury, particularly in individuals where renal prostaglandins play a critical role in maintaining renal perfusion. In patients with compromised liver function, the administration of an NSAID may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and potentially precipitate overt renal decompensation.

Patients at the highest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, individuals taking diuretics and ACE inhibitors, and the elderly. Therefore, it is crucial to exercise caution when considering NSAID therapy in this population.

Currently, there is no available information from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease. Consequently, treatment with ibuprofen tablets is not recommended for patients with advanced renal disease. If therapy with ibuprofen tablets is deemed necessary, close monitoring of renal function is advised to mitigate potential risks. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state, underscoring the importance of careful patient management.

Overdosage

In cases of ibuprofen overdosage, clinical manifestations can vary significantly based on the amount ingested and the timing of intervention.

A notable case involved a 19-month-old child who ingested between 7 to 10 ibuprofen tablets (400 mg). This child presented with apneic and cyanotic symptoms, necessitating oxygen supplementation and intravenous fluids. Blood analysis approximately 8½ hours post-ingestion revealed a concentration of 102.9 mcg/mL.

Conversely, two separate cases involving children weighing around 10 kg who ingested approximately 120 mg/kg of ibuprofen showed no signs of acute intoxication. Notably, one child's blood level was measured at 700 mcg/mL just 90 minutes after ingestion, indicating that significant variability in response can occur.

In an adult case, a 19-year-old male consumed 8,000 mg of ibuprofen over several hours. He experienced dizziness but ultimately recovered following parenteral hydration and three days of bed rest, highlighting the importance of supportive care in managing overdosage.

For the management of acute ibuprofen overdosage, it is recommended that the stomach be emptied through vomiting or gastric lavage within one hour of ingestion, as little drug will likely be recovered after this period. The administration of oral activated charcoal may also be beneficial in reducing both absorption and reabsorption of the drug. Additionally, due to the acidic nature of ibuprofen, administering alkali and inducing diuresis may enhance urinary excretion and facilitate the elimination of the drug from the body.

Healthcare professionals should remain vigilant for symptoms of overdosage and initiate appropriate management strategies promptly to mitigate potential complications.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy, particularly after approximately 20 weeks of gestation, has been associated with an increased risk of fetal renal dysfunction, leading to oligohydramnios and, in some instances, neonatal renal impairment. Furthermore, administration of NSAIDs around 30 weeks gestation or later may elevate the risk of premature closure of the fetal ductus arteriosus. Observational studies regarding other potential embryo-fetal risks associated with NSAID use during the first or second trimesters have yielded inconclusive results.

In animal reproductive studies conducted in rats and rabbits, no evidence of developmental abnormalities was observed; however, it is important to note that animal reproduction studies do not always predict human responses. Prostaglandins play a critical role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, the use of prostaglandin synthesis inhibitors, such as ibuprofen, has been linked to increased pre- and post-implantation loss. Additionally, prostaglandins are essential for fetal kidney development, and published animal studies indicate that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

Oligohydramnios, a potential consequence of renal dysfunction, is often reversible upon discontinuation of treatment; however, complications from prolonged oligohydramnios may include limb contractures and delayed lung maturation. In certain postmarketing cases of impaired neonatal renal function, invasive interventions such as exchange transfusion or dialysis were necessary.

No controlled clinical study data are available regarding the use of ibuprofen tablets in patients with advanced renal disease. Consequently, the use of ibuprofen tablets is not recommended for these patients. If therapy with ibuprofen tablets is deemed necessary, close monitoring of renal function is advised.

In animal studies, the administration of prostaglandin synthesis inhibitors, including ibuprofen, has resulted in increased pre- and post-implantation loss. Additionally, published animal studies have reported that these inhibitors can impair kidney development when given at clinically relevant doses.

Postmarketing Experience

Anaphylactoid reactions have been reported in patients without known prior exposure to ibuprofen tablets, necessitating emergency assistance in such cases. Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal, have also been documented. These serious events may occur without warning.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been observed in patients taking NSAIDs, including ibuprofen tablets, with some cases being fatal or life-threatening. In two postmarketing clinical studies, a higher incidence of decreased hemoglobin levels was noted than previously reported, with a decrease of 1 gram or more occurring in 17.1% of 193 patients on 1600 mg of ibuprofen daily for osteoarthritis and in 22.8% of 189 patients taking 2400 mg daily for rheumatoid arthritis. Additionally, positive stool occult blood tests and elevated serum creatinine levels were observed in these studies.

Observational studies from the Danish National Registry indicated that patients treated with NSAIDs in the post-myocardial infarction (MI) period faced an increased risk of reinfarction, cardiovascular-related death, and all-cause mortality, beginning in the first week of treatment. The incidence of death in the first year post-MI was reported as 20 per 100 person-years in NSAID-treated patients compared to 12 per 100 person-years in those not exposed to NSAIDs. Furthermore, a study within the Danish National Registry revealed that NSAID use in patients with heart failure heightened the risk of myocardial infarction, hospitalization for heart failure, and death.

Fluid retention and edema have been noted in some patients receiving NSAIDs. Long-term NSAID administration has been associated with renal papillary necrosis and other forms of renal injury. Renal toxicity has also been observed in patients where renal prostaglandins play a compensatory role in maintaining renal perfusion. Patients at the highest risk for renal reactions include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly.

A limited number of case reports have documented maternal NSAID use leading to neonatal renal dysfunction without oligohydramnios, with some cases being irreversible. Certain instances of neonatal renal dysfunction necessitated invasive treatments, such as exchange transfusion or dialysis.

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID, such as ibuprofen, and periodically throughout the course of treatment. Healthcare providers should encourage patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

Patients should be advised to remain vigilant for symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately. It is important to communicate that ibuprofen tablets, like other NSAIDs, may cause serious cardiovascular side effects, such as myocardial infarction or stroke, which could lead to hospitalization or even death. Although serious cardiovascular events can occur without warning, patients should be alert for the aforementioned signs and symptoms and seek medical advice if they observe any indicative signs.

Additionally, patients should be made aware that ibuprofen tablets can cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects, such as ulcers and bleeding, which may also result in hospitalization or death. Patients should be instructed to be alert for signs and symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis, and to seek medical advice if they experience any of these symptoms.

Patients should be advised to discontinue ibuprofen tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible. They should also be informed about the symptoms of congestive heart failure, such as shortness of breath, unexplained weight gain, or edema, and instructed to contact their healthcare provider if such symptoms occur.

It is crucial to inform patients about the warning signs and symptoms of hepatotoxicity, including nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms. If these occur, patients should be instructed to stop therapy and seek immediate medical attention.

Patients should also be made aware of the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat, and should be instructed to seek immediate emergency help if these symptoms arise.

Finally, healthcare providers should inform pregnant women to avoid the use of ibuprofen tablets and other NSAIDs starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus. If treatment with ibuprofen tablets is necessary for a pregnant woman between approximately 20 to 30 weeks gestation, she should be advised that monitoring for oligohydramnios may be required if treatment continues for longer than 48 hours.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20º to 25ºC (68º to 77ºF), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Clinicians should be vigilant in monitoring patients for signs or symptoms of gastrointestinal (GI) bleeding, as there is a risk of serious GI tract ulcerations and bleeding associated with the use of NSAIDs. For patients undergoing long-term treatment with NSAIDs, it is recommended that complete blood counts (CBC) and chemistry profiles be checked periodically to assess for potential adverse effects.

In cases where patients exhibit clinical signs and symptoms indicative of liver or renal disease, or if systemic manifestations such as eosinophilia or rash occur, ibuprofen tablets should be discontinued. Additionally, if abnormal liver tests persist or worsen, immediate cessation of the medication is advised.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Ibuprofen as submitted by REMEDYREPACK INC.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)