FDA label 28745eed-ef9e-95ac-e063-6394a90a42fb

BOXED WARNING Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). Ibuprofen Oral Suspension is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). Ibuprofen Oral Suspension is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). Gastrointestinal Risk NSAIDs cause an increased 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 use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ).

ADVERSE REACTIONS In patients taking ibuprofen or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, fluid retention, gastrointestinal experiences (including abdominal pain, bloating, constipation, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, vomiting), headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular) and tinnitus. Additional adverse experiences reported occasionally include: Body as a whole - fever, infection, sepsis Cardiovascular system - congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, syncope Digestive system - dry mouth, duodenitis, esophagitis, gastric or duodenal ulcer with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding Hemic and lymphatic system - ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, thrombocytopenia Metabolic and nutritional - weight changes Nervous system - anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, vertigo Respiratory system - asthma, dyspnea Skin and appendages - alopecia, photosensitivity, sweat Special senses - blurred vision Urogenital system - cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactions, which occur rarely are: Body as a whole - anaphylactic reactions, anaphylactoid reactions, appetite changes Cardiovascular system - arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, vasculitis Digestive system - eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, pancreatitis Hemic and lymphatic system - agranulocystosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, pancytopenia Metabolic and nutritional - hyperglycemia Nervous system - convulsions, coma, emotional lability, hallucinations, aseptic meningitis Respiratory - apnea, respiratory depression, pneumonia, rhinitis Skin and appendages - angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, fixed drug eruption (FDE), urticaria, vesiculobullous eruptions Special senses - amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision), conjunctivitis, dry eyes, hearing impairment Urogenital - azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, tubular necrosis

<table width="100%"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr styleCode="Toprule"><td valign="top"><paragraph>Body as a whole -</paragraph></td><td valign="top"><paragraph>fever, infection, sepsis</paragraph></td></tr><tr><td valign="top"><paragraph>Cardiovascular system -</paragraph></td><td valign="top"><paragraph>congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, syncope</paragraph></td></tr><tr><td valign="top"><paragraph>Digestive system -</paragraph></td><td valign="top"><paragraph>dry mouth, duodenitis, esophagitis, gastric or duodenal ulcer with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding</paragraph></td></tr><tr><td valign="top"><paragraph>Hemic and lymphatic system -</paragraph></td><td valign="top"><paragraph>ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, thrombocytopenia</paragraph></td></tr><tr><td valign="top"><paragraph>Metabolic and nutritional -</paragraph></td><td valign="top"><paragraph>weight changes</paragraph></td></tr><tr><td valign="top"><paragraph>Nervous system -</paragraph></td><td valign="top"><paragraph>anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, vertigo</paragraph></td></tr><tr><td valign="top"><paragraph>Respiratory system -</paragraph></td><td valign="top"><paragraph>asthma, dyspnea</paragraph></td></tr><tr><td valign="top"><paragraph>Skin and appendages -</paragraph></td><td valign="top"><paragraph>alopecia, photosensitivity, sweat</paragraph></td></tr><tr><td valign="top"><paragraph>Special senses -</paragraph></td><td valign="top"><paragraph>blurred vision</paragraph></td></tr><tr><td valign="top"><paragraph>Urogenital system -</paragraph></td><td valign="top"><paragraph>cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, acute renal failure in patients with pre-existing significantly impaired renal function</paragraph></td></tr><tr><td colspan="2" valign="top"><paragraph>Other adverse reactions, which occur rarely are:</paragraph></td></tr><tr><td valign="top"><paragraph>Body as a whole -</paragraph></td><td valign="top"><paragraph>anaphylactic reactions, anaphylactoid reactions, appetite changes</paragraph></td></tr><tr><td valign="top"><paragraph>Cardiovascular system -</paragraph></td><td valign="top"><paragraph>arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, vasculitis</paragraph></td></tr><tr><td valign="top"><paragraph>Digestive system -</paragraph></td><td valign="top"><paragraph>eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, pancreatitis</paragraph></td></tr><tr><td valign="top"><paragraph>Hemic and lymphatic system -</paragraph></td><td valign="top"><paragraph>agranulocystosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, pancytopenia</paragraph></td></tr><tr><td valign="top"><paragraph>Metabolic and nutritional -</paragraph></td><td valign="top"><paragraph>hyperglycemia</paragraph></td></tr><tr><td valign="top"><paragraph>Nervous system -</paragraph></td><td valign="top"><paragraph>convulsions, coma, emotional lability, hallucinations, aseptic meningitis</paragraph></td></tr><tr><td valign="top"><paragraph>Respiratory -</paragraph></td><td valign="top"><paragraph>apnea, respiratory depression, pneumonia, rhinitis</paragraph></td></tr><tr><td valign="top"><paragraph>Skin and appendages -</paragraph></td><td valign="top"><paragraph>angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, fixed drug eruption (FDE), urticaria, vesiculobullous eruptions</paragraph></td></tr><tr><td valign="top"><paragraph>Special senses -</paragraph></td><td valign="top"><paragraph>amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision), conjunctivitis, dry eyes, hearing impairment</paragraph></td></tr><tr styleCode="Botrule"><td valign="top"><paragraph>Urogenital -</paragraph></td><td valign="top"><paragraph>azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, tubular necrosis</paragraph></td></tr></tbody></table>