FDA label c8ef867b-4f84-4f37-8b77-6df5dc506de1

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
c1a8cb8b-b95d-429d-88db-4bffc219c8a4
SPL ID
c8ef867b-4f84-4f37-8b77-6df5dc506de1
Version
3
Effective date
2017-08-08
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:29

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

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: -more than 8 caplets in 24 hours, which is the maximum daily amount -with other drugs containing acetaminophen -3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if: -Symptoms do not improve -Pain gets worse or lasts for more than 10 days -Fever gets worse or lasts for more than 3 days -New symptoms occur -Redness or swelling is present -A rare sensitivity reaction occurs - You may report side effects to 1-888-952-0050 If pregnant of breast-feeding, ask a health professional before use. Do not exceed recommended dosage.

Reported adverse events (FAERS/openFDA)#

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