Label: IBU- ibuprofen tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 6, 2017

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  • BOXED WARNING (What is this?)

    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).
    • IBU tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (See CONTRAINDICATIONS and WARNINGS).

    Gastrointestinal Risk

    • NSAIDS cause an increased risk of serious gastrointestinaladverse events including bleeding, ulceration, and perforationof the stomach or intestines, which can be fatal. These eventscan occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious gastrointestinalevents. (See WARNINGS).
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  • DESCRIPTION
    IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly ...
  • CLINICAL PHARMACOLOGY
    IBU tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action, like that of other NSAIDs, isnot completely understood, but may be related to prostaglandin ...
  • INDICATIONS AND USAGE
    Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration ...
  • CONTRAINDICATIONS
    IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen. IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions ...
  • WARNINGS
    CARDIOVASCULAR EFFECTS - Cardiovascular Thrombotic Events - Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of ...
  • PRECAUTIONS
    General - IBU tablets cannot be expected to substitute for corticosteroids orto treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroidsmay lead to disease exacerbation ...
  • ADVERSE REACTIONS
    The most frequent type of adverse reaction occurring withIbuprofen tablets is gastrointestinal. In controlled clinical trials thepercentage of patients reporting one or more gastrointestinal ...
  • OVERDOSAGE
    Approximately 11⁄2 hours after the reported ingestion of from 7 to10 Ibuprofen tablets (400 mg), a 19-month old child weighing 12 kgwas seen in the hospital emergency room, apneic and ...
  • DOSAGE AND ADMINISTRATION
    Carefully consider the potential benefits and risks of IBU tabletsand other treatment options before deciding to use IBU tablets. Usethe lowest effective dose for the shortest duration consistent ...
  • HOW SUPPLIED
    Product: 50436-4605 - NDC: 50436-4605-2 60 TABLET in a BOTTLE - NDC: 50436-4605-1 30 TABLET in a BOTTLE - NDC: 50436-4605-3 90 TABLET in a BOTTLE
  • MEDICATION GUIDE
    Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs) What it the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs ...
  • IBUPROFEN 600MG TABLET
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  • INGREDIENTS AND APPEARANCE
    Product Information