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NDC 49483-0602-01

Ibuprofen 400 mg/1 TABLET, FILM COATED

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NDC
49483-0602-01
Generic Name
Ibuprofen
Brand Name
Ibuprofen
Strength
400 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Package Size
Labeler
TIME CAP LABORATORIES, INC

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE 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 duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also in…

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 upon available data, it is unclear that the risk for CV thrombotic events is similar…

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

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