Ibuprofen

Description

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is 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. Ibuprofen is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. The 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 these effects.

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 of ibuprofen tablets compared to those with osteoarthritis. The smallest effective dose that provides acceptable control should always be employed.

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

Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, has been associated with the use of Ibuprofen Tablets. This risk may manifest early in treatment and is likely to escalate with prolonged use. It is important to note that Ibuprofen Tablets are contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, can lead to significant gastrointestinal (GI) adverse events such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which may be fatal. These events can occur at any time during treatment and may present without warning symptoms. Therefore, patients on long-term NSAID therapy should be closely monitored for signs or symptoms of GI bleeding.

Patients with a recent myocardial infarction (MI) should avoid the use of Ibuprofen Tablets unless the potential benefits outweigh the risks of recurrent cardiovascular thrombotic events. Additionally, NSAIDs may induce new hypertension or exacerbate preexisting hypertension, thereby increasing the likelihood of cardiovascular complications. The use of Ibuprofen Tablets in patients with severe heart failure is also discouraged unless the benefits are deemed to outweigh the risks, and such patients should be monitored for signs of worsening heart failure.

Anaphylactoid reactions can occur in individuals without prior exposure to ibuprofen. In the event of an anaphylactoid reaction, immediate emergency medical assistance should be sought. Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), may arise without warning. Discontinuation of ibuprofen is advised at the first sign of a skin rash or any indication of hypersensitivity. Furthermore, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported and can be fatal or life-threatening; ibuprofen should be discontinued if any signs or symptoms of DRESS occur.

In pregnant women, the use of Ibuprofen Tablets is contraindicated around 30 weeks of gestation and later due to the risk of premature closure of the fetal ductus arteriosus and potential renal dysfunction in the fetus, which may lead to oligohydramnios.

Ibuprofen Tablets are not a substitute for corticosteroids and cannot treat corticosteroid insufficiency. If corticosteroids are being discontinued, they should be tapered slowly. Liver function tests should be monitored, as borderline elevations may occur in up to 15% of patients; discontinuation is warranted if clinical signs of liver disease develop. Long-term NSAID users should also have their hemoglobin or hematocrit levels monitored for signs of anemia.

Patients with asthma may exhibit aspirin-sensitive asthma and should not be administered Ibuprofen Tablets if this sensitivity is present. Regular monitoring of complete blood count (CBC) and chemistry profiles is recommended for patients on long-term NSAID treatment. If clinical signs of liver or renal disease develop, or if abnormal liver tests persist or worsen, ibuprofen should be discontinued.

In cases of anaphylactoid reactions, emergency medical help should be sought immediately. Patients should discontinue Ibuprofen Tablets at the first appearance of a skin rash or any other sign of hypersensitivity. If signs or symptoms of DRESS occur, ibuprofen should be discontinued, and the patient should be evaluated promptly.

Side Effects

Patients receiving treatment with non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may experience a range of adverse reactions. These reactions can be categorized by seriousness and frequency.

Serious adverse reactions include an increased risk of cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may manifest early in treatment and is known to increase with prolonged use. Additionally, NSAIDs are associated with a heightened risk of serious gastrointestinal events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. Such gastrointestinal complications can occur at any time during therapy and may present without warning symptoms, particularly in elderly patients who are at greater risk.

Gastrointestinal adverse reactions reported by patients include nausea, epigastric pain, heartburn, diarrhea, abdominal distress, and constipation. More severe gastrointestinal issues such as gastric or duodenal ulcers with bleeding or perforation, gastrointestinal hemorrhage, and pancreatitis have also been observed.

Central nervous system effects may include dizziness, headache, and nervousness, with more serious manifestations such as depression, insomnia, confusion, and aseptic meningitis, which can present with fever and coma. Patients have reported paresthesias, hallucinations, and dream abnormalities.

Dermatologic reactions can range from mild rashes and pruritus to severe conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and other serious skin reactions that may occur without warning.

Hematologic adverse reactions include neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia, with some patients experiencing bleeding episodes.

Metabolic and endocrine reactions may involve decreased appetite, gynecomastia, and hypoglycemic reactions. Cardiovascular effects can include edema, fluid retention, congestive heart failure in patients with marginal cardiac function, elevated blood pressure, and arrhythmias.

Renal adverse reactions have been noted, including acute renal failure, decreased creatinine clearance, and renal papillary necrosis.

Allergic reactions may present as anaphylaxis, bronchospasm, serum sickness, and angioedema. Aseptic meningitis has been reported in rare cases among patients on ibuprofen therapy, and anaphylactoid reactions may occur even in those without prior exposure to ibuprofen.

Miscellaneous adverse reactions include dry eyes and mouth, gingival ulcers, and rhinitis.

It is important for healthcare providers to monitor patients for these adverse reactions and to consider the potential for serious outcomes associated with NSAID therapy.

Drug Interactions

The co-administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and various other medications can lead to significant drug interactions that may impact therapeutic outcomes and patient safety.

Antihypertensive Agents NSAIDs may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors. Clinicians should monitor blood pressure and consider dosage adjustments of the antihypertensive medication as necessary.

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 in patients requiring antiplatelet therapy.

Diuretics The use of ibuprofen may reduce the natriuretic effect of furosemide and thiazide diuretics. Close monitoring for renal function is recommended in patients receiving these combinations to prevent renal failure.

Lithium Ibuprofen has been shown to elevate plasma lithium levels and reduce its renal clearance, which increases the risk of lithium toxicity. Regular monitoring of lithium levels is advised when these drugs are used concurrently.

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

Anticoagulants Co-administration of ibuprofen with warfarin-type anticoagulants may increase the risk of serious gastrointestinal bleeding. Clinicians should assess the need for additional monitoring of coagulation parameters and consider alternative pain management strategies.

H2-Receptor Antagonists The co-administration of cimetidine or ranitidine with ibuprofen does not significantly affect ibuprofen serum concentrations, indicating that no dosage adjustments are necessary for ibuprofen 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

The 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 after approximately 20 weeks of gestation. The administration of NSAIDs at about 30 weeks gestation or later can lead to premature closure of the fetal ductus arteriosus, which is a critical vessel in fetal circulation. Additionally, NSAID use during this period has been linked to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment.

Healthcare professionals are advised to limit the dose and duration of ibuprofen tablets use between approximately 20 and 30 weeks of gestation. If NSAID treatment is deemed necessary after 20 weeks, it should be restricted to the lowest effective dose for the shortest duration possible. Should treatment with ibuprofen tablets extend beyond 48 hours, monitoring for oligohydramnios via ultrasound is recommended. In instances where oligohydramnios is detected, ibuprofen tablets should be discontinued, and follow-up should be conducted according to clinical practice guidelines.

Data from observational studies regarding the risks of NSAID use during the first and second trimesters remain inconclusive. In the general U.S. population, the background rate of major malformations in clinically recognized pregnancies is 2-4%, with a pregnancy loss rate of 15-20%, regardless of drug exposure. Animal studies have not demonstrated developmental abnormalities with ibuprofen; however, these studies are not always predictive of human outcomes. There are no adequate and well-controlled studies in pregnant women, and ibuprofen should only be used during pregnancy if the potential benefits justify the potential risks to the fetus.

Furthermore, animal data suggest that prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and fetal kidney development. In animal studies, the use of prostaglandin synthesis inhibitors like ibuprofen has been associated with increased pre- and post-implantation loss and impaired kidney development at clinically relevant doses.

Published literature indicates that adverse outcomes, such as fetal renal dysfunction leading to oligohydramnios, may occur after days to weeks of NSAID treatment, although some cases of oligohydramnios have been reported as early as 48 hours post-initiation. While many instances of decreased amniotic fluid have been transient and reversible upon cessation of the drug, there are limited case reports of irreversible neonatal renal dysfunction requiring invasive interventions.

Due to methodological limitations in postmarketing studies, including the absence of control groups and insufficient data on dosage, duration, and timing of exposure, establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use remains challenging. The generalizability of reported risks to full-term infants exposed to NSAIDs through maternal use is also uncertain, as most safety data involve preterm infants.

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 effects 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 under careful supervision.

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 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, those taking diuretics and ACE inhibitors, and the elderly. Therefore, it is essential 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 and fluid administration. 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 acute signs of intoxication. Notably, one child's blood level was measured at 700 mcg/mL just 90 minutes after ingestion, indicating variability in individual responses to ibuprofen overdose.

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.

For the management of acute ibuprofen overdosage, it is critical to empty the stomach through vomiting or gastric lavage within one hour of ingestion, as little drug will likely be recovered after this period. The administration of alkali and the induction of diuresis may be beneficial due to the drug's acidic properties and its urinary excretion pathway. Additionally, oral activated charcoal can be utilized to reduce further absorption of the drug.

Supportive measures are paramount in the management of ibuprofen overdose. Healthcare professionals should closely monitor patients for signs of toxicity and provide appropriate care tailored to the severity of the symptoms presented.

Nonclinical Toxicology

Data from observational studies regarding potential embryo-fetal risks associated with NSAID use during the first or second trimesters of pregnancy remain inconclusive. In the general U.S. population, the background rate of major malformations in clinically recognized pregnancies is estimated at 2-4%, with a pregnancy loss rate of 15-20%, irrespective of drug exposure. Animal reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities; however, these studies may not always predict human responses. There are no adequate and well-controlled studies in pregnant women, and ibuprofen should be utilized during pregnancy only if the potential benefits outweigh the risks to the fetus.

Prostaglandins play a critical role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has resulted in 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.

The use of NSAIDs, including ibuprofen tablets, during approximately 20 weeks of gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. These adverse outcomes typically manifest after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours following the initiation of NSAID therapy. While oligohydramnios may be reversible upon discontinuation of treatment, prolonged oligohydramnios can lead to complications such as limb contractures and delayed lung maturation. In certain postmarketing cases of impaired neonatal renal function, invasive interventions like exchange transfusion or dialysis have been necessary.

If NSAID treatment is deemed necessary between approximately 20 weeks and 30 weeks of gestation, it is advised to limit the use of ibuprofen tablets to the lowest effective dose for the shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if treatment with ibuprofen tablets extends beyond 48 hours. Discontinuation of ibuprofen tablets is recommended if oligohydramnios occurs, with follow-up conducted according to clinical practice guidelines.

Long-term administration of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury. Renal toxicity has also been observed in patients for whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In such patients, NSAID administration may lead to a dose-dependent reduction in prostaglandin formation and, consequently, renal blood flow, potentially precipitating overt renal decompensation. Individuals at the highest risk for this reaction include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Typically, discontinuation of NSAID therapy results in recovery to the pretreatment state.

Postmarketing Experience

Anaphylactoid reactions have been reported in patients without known prior exposure to ibuprofen tablets, necessitating emergency assistance in such cases. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been documented in patients using NSAIDs, including ibuprofen, with some instances resulting in fatal or life-threatening outcomes.

Serious skin adverse events, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal, have been observed. Observational studies from the Danish National Registry indicate that patients treated with NSAIDs during the post-myocardial infarction (MI) period may experience an increased risk of reinfarction, cardiovascular-related death, and all-cause mortality, beginning within the first week of treatment.

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 observed in 17.1% of 193 patients receiving 1600 mg of ibuprofen daily and in 22.8% of 189 patients taking 2400 mg daily. Additionally, positive stool occult blood tests and elevated serum creatinine levels were recorded in these studies.

Reports indicate that NSAIDs may reduce the antihypertensive effect of ACE inhibitors. Clinical studies and postmarketing observations have shown that ibuprofen tablets can diminish the natriuretic effect of furosemide and thiazides in certain patients.

The use of NSAIDs, including ibuprofen tablets, around 20 weeks of gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some instances, neonatal renal impairment. Published studies and postmarketing reports corroborate the association between maternal NSAID use during this period and fetal renal dysfunction.

Patient Counseling

Patients should be informed of the symptoms associated with cardiovascular thrombotic events, which include chest pain, shortness of breath, weakness, or slurring of speech. They should be advised to report any of these symptoms to their healthcare provider immediately.

It is important for patients to understand that ibuprofen tablets may lead to serious cardiovascular side effects, such as myocardial infarction (MI) or stroke, potentially resulting in hospitalization or death. Patients should remain vigilant for signs and symptoms of these events and seek medical advice if they experience any indicative symptoms.

Patients should also be made aware that ibuprofen tablets can cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects, including ulcers and bleeding, which may necessitate hospitalization or could be fatal. They should be instructed to recognize signs and symptoms of ulcerations and bleeding, such as epigastric pain, dyspepsia, melena, and hematemesis, and to contact their healthcare provider if they observe any of these symptoms.

Healthcare providers should advise patients to discontinue ibuprofen tablets immediately if they develop any type of rash or fever and to reach out to their healthcare provider as soon as possible.

Patients should be alert for symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema, and should be instructed to contact their healthcare provider if such symptoms occur.

Patients must be informed about the warning signs and symptoms of hepatotoxicity, which may include nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms. If these symptoms arise, patients should be directed to stop therapy and seek immediate medical attention.

Additionally, patients should be educated on the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. In the event of these symptoms, patients should be instructed to seek immediate emergency help.

Pregnant women should be advised 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 informed 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 for identification. 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), to maintain product integrity.

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)