Drug Safety-related Labeling Changes (SrLC)

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ALEVE-D SINUS & COLD (NDA-021076)

(NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE)

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

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04/06/2020 (SUPPL-16)

Approved Drug Label (PDF)

5 Warnings and Precautions

(Additions and/or revisions underlined)

Ask a doctor or pharmacist before use if you are:

  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin

09/12/2017 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Addition of the following to the Drug Facts Label

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.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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