FDA label 44ebf063-0a6f-72d3-e063-6394a90a3475

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
f3e21ed8-c9be-470e-a5d0-25b811b4933c
SPL ID
44ebf063-0a6f-72d3-e063-6394a90a3475
Version
7
Effective date
2025-12-01
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:05:19

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 casue a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives, facial swelling, asthma(wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away Stomach bleeding warning: This product contains NSAID, which may casue severe 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 prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or mre alcoholic drinks everyday while using this product, take more or for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the rist 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. Do not use Do not use: If you have ever had an allergic reaction to any other pain reliever/fever reducer. Right before or after heart surgery When using this product 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 of for longer than directed Ask a Doctor Ask a doctor before use if: Stomach bleeding warning applies to you You have a history of stomach problems, such as heartburn You have high blood pressure, heart disease, liver cirrhosis, or kidney disease You are taking a diuretic You have problems or serious side effects from taking paiin relievers or fever reducers You have asthma Ask a doctor or pharmacist before use if you are: under a doctors care for any serious condition Taking any other drug

Reported adverse events (FAERS/openFDA)#

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