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NDC 69292-0550-01

diclofenac potassium 50 mg/1 TABLET, FILM COATED

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NDC
69292-0550-01
Generic Name
diclofenac potassium
Brand Name
Diclofenac Potassium
Strength
50 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Package Size
Labeler
Amici Pharma Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are indicated: For treatment of primary dysmenorrhea For relief of mild to moderate pain For relief of t…

Important Warnings

WARNINGS 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 serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The rela…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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