Ibuprofen

Description

Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is chemically defined as (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen appears as a white powder with a melting point ranging from 74° to 77° C. It exhibits very slight solubility in water, with a solubility of less than 1 mg/mL, while being readily soluble in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is provided below.

These tablets are formulated as a nonsteroidal anti-inflammatory drug (NSAID) and are available in a dosage strength of 600 mg for oral administration. The formulation includes several inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, 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.

Limitations of Use: Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in pediatric patients have not been conducted. Therefore, the use of this medication in children is not recommended until further data is available.

Dosage and Administration

For the treatment 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 administered as 300 mg four times a day (qid) or as 400 mg, 600 mg, or 800 mg three to four times a day (tid or qid). Individual patient responses may vary, with some patients showing a better response at the higher end of the dosage range (3200 mg daily) compared to 2400 mg.

The total daily dose should not exceed 3200 mg. In cases where gastrointestinal complaints arise, it is recommended to administer Ibuprofen Tablets with meals or milk to mitigate these effects. The dosage should be tailored to each patient and may be adjusted based on the severity of symptoms.

For the management of mild to moderate pain, a dosage of 400 mg may be taken every 4 to 6 hours as needed for pain relief. In the case of dysmenorrhea, a dosage of 400 mg every 4 hours may be administered as necessary for pain relief.

After the initial therapy, healthcare professionals should observe the patient's response and adjust the dose and frequency accordingly to meet individual needs. A therapeutic response may be observed within a few days to a week, but is most commonly seen by two weeks. Following a satisfactory response, it is advisable to review and adjust the patient's dosage as required.

Contraindications

Ibuprofen Tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Additionally, the use of Ibuprofen Tablets is not recommended for individuals who have a history of asthma, urticaria, or allergic-type reactions following the administration of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), as severe, potentially fatal, anaphylactic-like reactions have been reported in these patients.

Furthermore, Ibuprofen Tablets are contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Nonsteroidal 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 can also lead to the development of new hypertension or exacerbate existing hypertension, potentially increasing the incidence of cardiovascular events. Therefore, it is imperative that blood pressure is monitored closely during the initiation of therapy and throughout the treatment course.

Gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, can occur with NSAID use and may be fatal. These serious adverse events can arise at any time, with or without prior warning symptoms.

In patients with severe heart failure, the use of Ibuprofen may diminish the cardiovascular effects of certain therapeutic agents. It should be avoided unless the potential benefits are deemed to outweigh the associated risks.

Anaphylactoid reactions may occur in individuals without a known history of exposure to Ibuprofen Tablets. In such cases, immediate emergency medical assistance should be sought.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported and can be fatal. Patients should discontinue Ibuprofen Tablets at the first sign of a skin rash or any other indication of hypersensitivity. Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been documented in patients taking NSAIDs, which can be life-threatening. If signs or symptoms of DRESS are observed, Ibuprofen Tablets should be discontinued, and the patient should be evaluated immediately.

In terms of general precautions, the use of Ibuprofen Tablets in patients with a recent myocardial infarction is discouraged unless the anticipated benefits outweigh the risks of recurrent cardiovascular thrombotic events. Monitoring for signs of cardiac ischemia is recommended in these patients.

The administration of Ibuprofen Tablets in individuals with advanced renal disease is not advised; however, if treatment is necessary, renal function should be closely monitored. Furthermore, the use of NSAIDs, including Ibuprofen Tablets, during pregnancy, particularly after approximately 20 weeks of gestation, may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment. Therefore, it is essential to limit the use of Ibuprofen to the lowest effective dose for the shortest duration possible.

Monitoring parameters include regular assessment of blood pressure during NSAID treatment and close observation of renal function in patients with advanced renal disease. Emergency medical help should be sought in cases of anaphylactoid reactions. Patients should discontinue Ibuprofen Tablets at the first appearance of any skin rash or signs of hypersensitivity and should be evaluated immediately if symptoms of DRESS occur.

Side Effects

Patients receiving treatment with this medication may experience a range of adverse reactions. 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, there is a significant risk of serious gastrointestinal events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. These gastrointestinal complications can occur at any time during therapy and may present without warning symptoms, particularly in elderly patients who are at greater risk.

Common adverse reactions, occurring in more than 1% but less than 3% of patients, include gastrointestinal symptoms such as nausea, epigastric pain, heartburn, diarrhea, abdominal distress, and constipation. Central nervous system effects may include dizziness, headache, and nervousness. Dermatologic reactions such as rash (including maculopapular types) and pruritus have also been reported. Other common reactions include decreased appetite, edema, fluid retention, and tinnitus.

Adverse reactions with a precise incidence unknown but occurring in less than 1% of patients may include serious gastrointestinal complications such as gastric or duodenal ulcers with bleeding or perforation, gastrointestinal hemorrhage, and pancreatitis. Central nervous system effects may encompass depression, insomnia, confusion, emotional liability, somnolence, and aseptic meningitis with fever and coma. Dermatologic reactions may include vesiculobullous eruptions, urticaria, erythema multiforme, alopecia, and severe conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Hematologic reactions may involve neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia. Renal adverse reactions may include acute renal failure, decreased creatinine clearance, and hematuria.

Other less common reactions with an unknown causal relationship include paresthesias, hallucinations, and dream abnormalities. Cardiovascular issues such as congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, and arrhythmias have also been noted. Allergic reactions may present as a syndrome of abdominal pain, fever, chills, and anaphylaxis. Miscellaneous reactions include dry eyes and mouth, gingival ulcers, and exfoliative dermatitis.

Postmarketing experience has revealed additional serious dermatologic reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and fixed drug eruption.

Drug Interactions

Concomitant use of Ibuprofen Tablets with certain medications may lead to significant drug interactions, which can affect therapeutic outcomes and safety. The following interactions have been identified:

Pharmacodynamic Interactions

• ACE-Inhibitors: Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may reduce the antihypertensive effect of ACE-inhibitors. Clinicians should consider this interaction when prescribing NSAIDs to patients who are concurrently taking ACE-inhibitors.

• Aspirin: The antiplatelet activity of aspirin may be compromised when ibuprofen is administered, particularly at a dose of 400 mg three times daily, and especially if ibuprofen is taken before aspirin. To mitigate this interaction, it is recommended that immediate-release low-dose aspirin be taken at least 2 hours prior to ibuprofen. However, this timing does not apply to enteric-coated low-dose aspirin. Due to the potential increased risk of cardiovascular events, alternative analgesics that do not interfere with aspirin's antiplatelet effect should be considered for patients using low-dose aspirin for cardioprotection.

• Warfarin-Type Anticoagulants: While short-term studies have not shown significant effects of ibuprofen on prothrombin times in patients on coumarin-type anticoagulants, there is a documented risk of increased bleeding. Caution is advised when administering ibuprofen to patients on anticoagulants, as the combined use may elevate the risk of serious gastrointestinal bleeding.

Pharmacokinetic Interactions

• Diuretics: Ibuprofen may diminish the natriuretic effect of diuretics such as furosemide and thiazides, likely due to inhibition of renal prostaglandin synthesis. Patients should be monitored closely for signs of renal impairment and to ensure the efficacy of diuretics during concurrent therapy.

• Lithium: The co-administration of ibuprofen has been shown to increase plasma lithium levels and decrease renal clearance of lithium. A 15% increase in mean minimum lithium concentration and a 19% reduction in renal clearance were observed. Patients receiving both ibuprofen and lithium should be closely monitored for signs of lithium toxicity.

• Methotrexate: NSAIDs may competitively inhibit the accumulation of methotrexate, potentially enhancing its toxicity. Caution is warranted when these agents are used together.

Other Interactions

• H-2 Antagonists: Co-administration of ibuprofen with H-2 antagonists such as cimetidine or ranitidine does not appear to significantly affect ibuprofen serum concentrations, indicating no major interaction.

In summary, careful consideration and monitoring are advised when ibuprofen is used in conjunction with these medications to mitigate potential adverse effects and ensure therapeutic efficacy.

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 this medication in children. Further studies are needed to determine appropriate dosing and outcomes in this population.

Geriatric Use

Caution should be exercised when treating elderly patients, specifically those aged 65 years and older. Due to the potential for altered pharmacokinetics and increased sensitivity to medications in this population, careful consideration of dosage adjustments and monitoring is essential. Healthcare providers are advised to assess the individual health status and comorbidities of geriatric patients to ensure safe and effective treatment.

Pregnancy

Use of NSAIDs, including Ibuprofen Tablets, during pregnancy is associated with significant risks, particularly when administered around 30 weeks of gestation or later. The use of these medications can lead to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which may result in oligohydramnios and, in some cases, neonatal renal impairment. Therefore, it is recommended to avoid the use of Ibuprofen Tablets at approximately 30 weeks of gestation and later. If NSAID use is deemed necessary between 20 and 30 weeks of gestation, it should be limited to the lowest effective dose for the shortest duration possible.

Observational studies have indicated that the use of NSAIDs at about 20 weeks of gestation or later is associated with fetal renal dysfunction leading to oligohydramnios, with some reports of 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 of NSAID therapy. In many instances, the decrease in amniotic fluid was transient and reversible upon discontinuation of the drug. However, there have been limited case reports of neonatal renal dysfunction occurring without oligohydramnios, some of which were irreversible and required invasive treatments such as exchange transfusion or dialysis.

Reproductive studies in rats and rabbits have not shown evidence of developmental abnormalities; however, animal studies are not always predictive of human outcomes. Prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and fetal kidney development. In animal studies, the administration of prostaglandin synthesis inhibitors like ibuprofen has been linked to increased pre- and post-implantation loss and impaired kidney development at clinically relevant doses.

The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population(s) remains unknown. There are no adequate, well-controlled studies in pregnant women, and Ibuprofen Tablets should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. If treatment with Ibuprofen Tablets extends beyond 48 hours, monitoring with ultrasound for oligohydramnios is advised, and if oligohydramnios is detected, the medication should be discontinued and follow-up should be conducted according to clinical practice.

The effects of Ibuprofen Tablets on labor and delivery in pregnant women are currently unknown. Methodological limitations in postmarketing studies and reports, including the lack of control groups and limited information regarding dose, duration, and timing of drug exposure, hinder the establishment of a reliable estimate of the risk of adverse fetal and neonatal outcomes associated with maternal NSAID use. Additionally, the generalizability of reported risks to full-term infants exposed to NSAIDs through maternal use remains 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; therefore, the use of NSAIDs may lead to a dose-dependent reduction in prostaglandin formation and, subsequently, renal blood flow. This can precipitate overt renal decompensation, particularly in patients at greatest risk, including those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly.

Discontinuation of NSAID therapy typically results in recovery to the pretreatment state. However, there is no available information from controlled clinical studies regarding the use of Ibuprofen Tablets in patients with advanced renal disease, and treatment with Ibuprofen Tablets is not recommended in this population. If therapy with Ibuprofen Tablets is deemed necessary, close monitoring of the patient's renal function is advised.

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 the use of 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 have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

Approximately 1½ hours following the ingestion of 7 to 10 Ibuprofen Tablets (400 mg) by a 19-month-old child weighing 12 kg, the child presented to the hospital emergency room in a state of apnea and cyanosis, responding only to painful stimuli. This stimulus was sufficient to induce respiration. Upon admission, the child received oxygen and parenteral fluids, and a greenish-yellow fluid was aspirated from the stomach, revealing no evidence of ibuprofen. Two hours post-ingestion, the child's condition appeared stable; however, she continued to respond solely to painful stimuli and experienced intermittent apnea lasting 5 to 10 seconds. The child was subsequently admitted to intensive care, where sodium bicarbonate, along with infusions of dextrose and normal saline, was administered. By four hours after ingestion, the child could be easily aroused, sit independently, and respond to verbal commands. A blood level of ibuprofen measured 102.9 mcg/mL approximately 8½ hours post-ingestion, and by 12 hours, the child appeared to have fully recovered.

In two additional reported cases involving children, each weighing approximately 10 kg, accidental acute ingestion of approximately 120 mg/kg of ibuprofen resulted in no signs of acute intoxication or late sequelae. Notably, one child's blood level was recorded at 700 mcg/mL 90 minutes after ingestion, which is about ten times the peak levels observed in absorption-excretion studies.

A case involving a 19-year-old male who ingested 8,000 mg of ibuprofen over several hours presented with dizziness, and nystagmus was observed. Following hospitalization, the patient received parenteral hydration and underwent three days of bed rest, ultimately recovering without any reported sequelae.

In instances of acute overdosage, it is recommended that the stomach be emptied through vomiting or gastric lavage; however, it should be noted that minimal drug recovery is likely if more than one hour has passed since ingestion. Given the acidic nature of ibuprofen and its urinary excretion, administering alkali and inducing diuresis may be theoretically beneficial. Supportive measures should be implemented, and the use of oral activated charcoal may assist in reducing both the absorption and reabsorption of ibuprofen.

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, which may lead to oligohydramnios and, in some instances, neonatal renal impairment. Furthermore, administration of NSAIDs around 30 weeks gestation or later has been linked to the premature closure of the fetal ductus arteriosus.

In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has resulted in increased pre- and post-implantation loss. Prostaglandins play a crucial role in fetal kidney development, and evidence from published animal studies indicates that the use of prostaglandin synthesis inhibitors at clinically relevant doses can impair kidney development.

Reproductive studies conducted in rats and rabbits have not shown evidence of developmental abnormalities; however, it is important to note that animal reproduction studies do not always predict human responses. The estimated background risk of major birth defects and miscarriage in the indicated populations remains unknown, as all pregnancies carry a baseline risk of birth defects, loss, or other adverse outcomes. Data from observational studies regarding potential embryofetal risks associated with NSAID use during the first or second trimesters of pregnancy are inconclusive.

Postmarketing Experience

Anemia has been reported in patients receiving NSAIDs, including Ibuprofen Tablets. This condition may arise from fluid retention, occult or gross gastrointestinal blood loss, or an incompletely characterized effect on erythropoiesis. It is recommended that patients undergoing long-term NSAID treatment, including Ibuprofen Tablets, have their hemoglobin or hematocrit levels monitored if they exhibit any signs or symptoms of anemia.

In two postmarketing clinical studies, the incidence of decreased hemoglobin levels was found to be higher than previously documented. A decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients taking 1600 mg of ibuprofen daily for osteoarthritis, and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily for rheumatoid arthritis. Additionally, positive stool occult blood tests and elevated serum creatinine levels were noted in these studies.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients using NSAIDs, including Ibuprofen Tablets. Some cases of DRESS have resulted in fatal or life-threatening outcomes. This syndrome typically presents with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling, although other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Symptoms of DRESS may sometimes mimic those of an acute viral infection, and eosinophilia is frequently observed.

A limited number of case reports have documented maternal NSAID use associated with neonatal renal dysfunction in the absence of oligohydramnios, with some cases resulting in irreversible damage. Certain instances of neonatal renal dysfunction necessitated invasive treatments, including exchange transfusion or dialysis.

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID, such as Ibuprofen Tablets, and periodically throughout the course of treatment. It is important for patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

Healthcare providers should advise patients to be vigilant for symptoms of cardiovascular thrombotic events, which may include chest pain, shortness of breath, weakness, or slurring of speech. Patients should be instructed to report any of these symptoms to their healthcare provider immediately.

Patients should be made aware that Ibuprofen Tablets, like other NSAIDs, can cause gastrointestinal (GI) discomfort and, in rare cases, serious GI side effects such as ulcers and bleeding, which may lead to hospitalization or even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for signs and symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis. They should be encouraged to seek medical advice if they observe any indicative signs or 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. Additionally, patients should be alert for symptoms of congestive heart failure, such as shortness of breath, unexplained weight gain, or edema, and should contact their healthcare provider if such symptoms occur.

It is crucial to inform patients 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 occur, patients should be instructed to stop therapy and seek immediate medical attention.

Patients should also be informed of the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. In such cases, 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.

Healthcare providers should monitor patients for signs or symptoms of GI bleeding, as serious GI tract ulcerations and bleeding can occur without warning symptoms. Furthermore, patients on long-term treatment with NSAIDs should have their complete blood count (CBC) and chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash), or if abnormal liver tests persist or worsen, Ibuprofen Tablets should be discontinued.

Storage and Handling

The product is supplied in a tight, light-resistant container as defined by the United States Pharmacopeia (USP). It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Additional Clinical Information

Physicians should monitor patients on long-term treatment with NSAIDs, including Ibuprofen Tablets, for signs or symptoms of gastrointestinal bleeding. It is recommended that patients have their complete blood count (CBC) and chemistry profile checked periodically. If any clinical signs or symptoms indicative of liver or renal disease develop, or if abnormal liver tests persist or worsen, discontinuation of Ibuprofen Tablets is advised.

Patients should be counseled to remain vigilant for symptoms of cardiovascular thrombotic events, such as chest pain and shortness of breath, and to report these to their healthcare provider immediately. They should also be aware of signs of ulcerations and bleeding, including epigastric pain and melena, and seek medical advice if these occur. Immediate discontinuation of Ibuprofen Tablets is recommended if any rash or fever develops, and patients should contact their healthcare provider. Additionally, patients should be informed about the symptoms of congestive heart failure, hepatotoxicity, and anaphylactoid reactions, and instructed to seek immediate medical attention if these symptoms arise. Pregnant women should avoid using Ibuprofen Tablets and other NSAIDs starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus, and those requiring treatment between 20 to 30 weeks gestation should be monitored for oligohydramnios if treatment exceeds 48 hours.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Ibuprofen as submitted by Amneal Pharmaceuticals of New York LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)