Label: IBUPROFEN suspension

  • NDC Code(s): 51672-1385-8, 51672-1385-9
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • BOXED WARNING (What is this?)
    Cardiovascular Thrombotic Events - Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke ...

    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 WARNINGSand PRECAUTIONS).
    • Ibuprofen oral suspension is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONSand 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
    The active ingredient in ibuprofen oral suspension USP is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics - Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that possesses anti-inflammatory, analgesic and antipyretic activity. Its mode of action, like that of other NSAIDs ...
  • INDICATIONS AND USAGE
    Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest ...
  • CONTRAINDICATIONS
    Ibuprofen is contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen 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 - Ibuprofen cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation ...
  • ADVERSE REACTIONS
    In patients taking ibuprofen or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Abnormal renal function, anemia, dizziness ...
  • OVERDOSAGE
    The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate ...
  • DOSAGE AND ADMINISTRATION
    Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen oral suspension. Use the lowest effective dose for the ...
  • HOW SUPPLIED
    Ibuprofen Oral Suspension USP, 100 mg/5 mL - White to off-white, berry-flavored suspension - - Bottles of 4 fl oz (118 mL) - NDC 51672-1385-8 - - Bottles of ONE PINT (473 mL) - NDC ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 - Distributed by: Taro Pharmaceuticals U.S.A., Inc.,Hawthorne, NY 10532 - Revised: March 2021 - 5214230 ...
  • Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
    What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of ...
  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
    NDC 51672-1385-8 - Ibuprofen - Oral Suspension USP - 100 mg / 5 mL - ATTENTION - PHARMACIST: Dispense the - accompanying - Medication Guide to - each patient ...
  • INGREDIENTS AND APPEARANCE
    Product Information