FDA label 386b5f2b-fd2b-4919-8b95-7836bd26097b

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
b2a70284-f183-4d65-928e-057709f32a1f
SPL ID
386b5f2b-fd2b-4919-8b95-7836bd26097b
Version
3
Effective date
2016-11-28
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 01:52:52

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. Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, with other drugs containing acetaminophen (prescription or non-prescription), or have 3 or more alcoholic drinks every day while using this product. Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, are age 60 or older, have 3 or more alcoholic drinks every day while using this product, take with other drugs containing an NSAID, or take more or for a longer time than directed.

Reported adverse events (FAERS/openFDA)#

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