FDA label e9ad6a60-d765-4fa6-a155-b7e1e1bfc733

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
0fabf67c-5046-4272-b49c-17a3a0ba2fc7
SPL ID
e9ad6a60-d765-4fa6-a155-b7e1e1bfc733
Version
1
Effective date
2012-09-04
Source export date
2026-10-12
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/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:48:27

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 WARNING 1. When those who drink alcohol over three glasses every day regularly with to take this drug or other antipyretic and analgesic, they must consult a doctor or pharmacist. Gastrointestinal bleeding may occur when these people take this drug. 2. Cardiovascular risks: Administering non-steroidal anti-inflammatory drugs (NSAIDs) including this product may lead to severe cardiovascular thrombotic response, myocardial infaction, and stroke. The possibility of abnormal cardiovascular reaction increases in patients with a period. Adverse reactions should be carefully monitored while an adverse reaction occurs. 3. Gastrointestinal risk: Administering NSAIDs including this product may cause severe gastrointestinal adverse reactions that may develop without any warning signs during the administration period. The risk of these adverse reactions increases in old age (elderly people) or in patients who have taken this drug for a long period.

Reported adverse events (FAERS/openFDA)#

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