FDA label 433cea3e-a3c4-4844-923b-2adad620fffc

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
2247e68f-60ba-42fc-b617-2fc2843994a5
SPL ID
433cea3e-a3c4-4844-923b-2adad620fffc
Version
2
Effective date
2018-05-09
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:40:26

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ asthma (wheezing) ■ skin reddening ■ blisters ■ facial swelling ■ shock ■ rash If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery Ask a doctor before use if you have ■ problems or serious side effects from taking pain relievers or fever reducers ■ stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ■ ulcers ■ asthma ■ bleeding problems ■ high blood pressure ■ heart or kidney disease ■ taken a diuretic ■ reached age 60 or older Ask a doctor or pharmacist before use if you are ■ taking any other drug containing an NSAID (prescription or nonprescription) ■ taking a blood thinning (anticoagulant) or steroid drug ■ under a doctor’s care for any serious condition ■ taking any other drug When using this product ■ take with food or milk if stomach upset occurs ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if ■ you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ you have difficulty swallowing ■ it feels like the pill is stuck in your throat ■ you develop heartburn ■ stomach pain or upset gets worse or lasts ■ redness or swelling is present in the painful area ■ any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.