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NDC 62559-0251-01

Etodolac 300 mg/1 CAPSULE

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NDC
62559-0251-01
Generic Name
Etodolac
Brand Name
Etodolac
Strength
300 mg/1
Dosage Form
CAPSULE
Route
ORAL
Package Size
Labeler
ANI Pharmaceuticals, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac capsules are indicated: • For acute and long-term use in the management of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis • For the management of acute pain

Important Warnings

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 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 f…

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

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