Label:
DICLOFENAC SODIUM DELAYED RELEASE- diclofenac sodium tablet, delayed release
DICLOFENAC SODIUM DELAYED RELEASE- diclofena...
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  • NDC Code(s): 61442-101-01, 61442-101-10, 61442-101-60, 61442-102-01, view more
  • Packager: Carlsbad Technology, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 6, 2024

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  • SPL UNCLASSIFIED SECTION
    Delayed-Release Tablets USP - Rx only - Prescribing information
  • 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 ...

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    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).
    • Diclofenac sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS).

    Gastrointestinal Bleeding, Ulceration, And Perforation

    • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS).
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  • DESCRIPTION
    Diclofenac sodium delayed-release tablets is a benzene-acetic acid derivative. Diclofenac sodium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac, like that of other NSAIDs, is not completely understood but ...
  • INDICATIONS AND USAGE
    Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for ...
  • CONTRAINDICATIONS
    Diclofenac sodium delayed-release tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any ...
  • WARNINGS
    Cardiovascular Thromboic Events - Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three - years duration have shown an increased risk of serious cardiovascular (CV ...
  • PRECAUTIONS SECTION
    General - Diclofenac sodium delayed-release tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may ...
  • ADVERSE REACTIONS SECTION
    The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see - WARNINGS) GI Bleeding, Ulceration and Perforation ...
  • OVERDOSAGE
    Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care ...
  • DOSAGE AND ADMINISTRATION
    Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for ...
  • HOW SUPPLIED
    Diclofenac sodium delayed-release tablets - 50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted - on one side), supplied in bottles of 60, 100 and 1000. Bottles of 60 ...
  • MEDICATION GUIDE
    Medication Guide for Nonsteroidal - Anti-Inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Principal Display Panel – Bottle Label - NDC 61442-101-60 - Diclofenac Sodium - Delayed-Release Tablets USP - 25 mg - PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE - Rx ...
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Bottle Label - NDC 61442-102-60 - Diclofenac Sodium - Delayed-Release Tablets USP - 50 mg - PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE - Rx Only - Carlsbad Technology, Inc. 60 ...
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Bottle Label - NDC 61442-103-60 - Diclofenac Sodium - Delayed-Release Tablets USP - 75 mg - PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE - Rx Only - Carlsbad Technology, Inc. 60 ...
  • INGREDIENTS AND APPEARANCE
    Product Information