FDA label 7f2110ff-0645-4106-8d8d-058bee3097aa

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
9968232c-6039-4f4a-a51d-093c543192db
SPL ID
7f2110ff-0645-4106-8d8d-058bee3097aa
Version
5
Effective date
2019-09-21
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:37

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

WARNING: Reye's Syndrome Warning: 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) • 3 or more alcoholic drinks every day while using this product. Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory 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 • 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.