FDA label 5b692155-67f6-49cb-b296-9b511cbbefbe

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
8fbcdbfb-b3d0-4ec3-9510-78a1acfc1976
SPL ID
5b692155-67f6-49cb-b296-9b511cbbefbe
Version
3
Effective date
2015-09-17
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:04

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 4000 mg of acetaminophen in 24 hours -with other drugs containing acetaminophen -3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include skin reddening, blisters, rash. If a skin reaction occurs, stop use and seek medical help right away. 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.