Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated December 12, 2024

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  • BOXED WARNING (What is this?)

    Cardiovascular Thrombotic Events                   


    ·  Non-steroidal 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 Tablets 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).

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  • 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 and is very slightly ...
  • CLINICAL PHARMACOLOGY
    Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to ...
  • INDICATIONS AND USAGE
    Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration ...
  • CONTRAINDICATIONS
    Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or ...
  • 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 - Ibuprofen tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease ...
  • ADVERSE REACTIONS
    The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal ...
  • OVERDOSAGE
    Approximately 1½ hours after the reported ingestion of from 7 to10 ibuprofen tablets (400 mg), a 19-month old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic ...
  • DOSAGE AND ADMINISTRATION
    Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest ...
  • HOW SUPPLIED
    Ibuprofen tablets are available in the following strengths, colors and sizes: 600 mg (white to off-white, caplet, 'I 7' debossing on one side and plain on the other side) NDC: 70518-0761-00 - NDC ...
  • Medication Guide
    Medication Guide For Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Ibuprofen - GENERIC: Ibuprofen - DOSAGE: TABLET, FILM COATED - ADMINSTRATION: ORAL - NDC: 70518-0761-0 - NDC: 70518-0761-1 - NDC: 70518-0761-2 - NDC: 70518-0761-3 - NDC: 70518-0761-4 - NDC: 70518-0761-5 - NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information