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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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03/02/2022 (SUPPL-17)

Approved Drug Label (PDF)

5 Warnings and Precautions

DRUG FACTS

WARNINGS:

Additions and/or revisions underlined: 

It is especially important not to use naproxen sodium 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.

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.