FDA label c89a9aca-1876-448a-938e-c2b82f271206

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
792909b7-1093-465e-91a1-10df1788aa32
SPL ID
c89a9aca-1876-448a-938e-c2b82f271206
Version
2
Effective date
2021-05-19
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:38:20

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: Reye’s Syndrome : • Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin Allergy Alert - Do not use: • if you are allergic to aspirin or any other salicylate • if you have ever had an allergic reaction to any other pain reliever/fever reducer Stomach Bleeding Warning: This product contains nonsteroidal anti-inflammatory drugs (NSAIDs), 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) • take more or for a longer time than directed Do not use: • with any other pain reliever/fever reducer Ask doctor before using if you have: • upset stomach or stomach pain • ulcers • 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 Stop use and ask a doctor if: ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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.