FDA label 3868bd32-db87-f58d-e063-6394a90a4abb

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
7b1c6ca4-f300-5cd0-e053-2991aa0a7ea8
SPL ID
3868bd32-db87-f58d-e063-6394a90a4abb
Version
3
Effective date
2025-06-25
Source export date
2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:11:20

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 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 a 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 - if you are not sure whether a drug contains acetaminophen - ask a doctor or pharmacist for more than 10 days for pains unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have: liver disease. Ask a doctor before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days ever gets worse or lasts more than 3 days redness or swelling is present. 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. Overdose warning. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not noti ce any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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