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NDC 51672-1385-09

Ibuprofen 100 mg/5mL SUSPENSION

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NDC
51672-1385-09
Generic Name
Ibuprofen
Brand Name
Ibuprofen
Strength
100 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Package Size
Labeler
Sun Pharmaceutical Industries, Inc.

FDA Drug Information

Indications & Usage

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 duration consistent with individual patient treatment goals (see WARNINGS ). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: For reduction of fever in patients aged 6 months up to 2 years of age. For relief of mild to moderate pain in patients aged 6 months up to 2 years o…

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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