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Drug Safety-related Labeling Changes (SrLC)

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ADVIL (NDA-018989)

(IBUPROFEN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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12/14/2021 (SUPPL-99)

Approved Drug Label (PDF)

5 Warnings and Precautions

DRUG FACTS

Subsection revised; revision underlined

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

08/23/2017 (SUPPL-88)

Approved Drug Label (PDF)

5 Warnings and Precautions

Warnings

(Additions and/or revisions are underlined)

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Ask a doctor before use if

•         you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

Stop use and ask a doctor if

•         you have symptoms of heart problems or stroke:

o       chest pain

o       trouble breathing

o       weakness in one part or side of body

o       slurred speech

o       leg swelling