FDA label eeba8cfe-fd6d-434d-8bab-c681570fe16e

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
583b5f8d-780c-429e-9384-d2adcee828c6
SPL ID
eeba8cfe-fd6d-434d-8bab-c681570fe16e
Version
8
Effective date
2017-05-08
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:07

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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 12 tablets in 24 hours,which is the maximum daily amount • child takes more than 5 tablets in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if the user has liver disease Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if • adult's pain gets worse or lasts more than 10 days • child's pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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