FDA label ae5d9540-a988-4072-9a46-b2bfcb4fd3a1

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
1d975dea-6135-4560-b62e-fa31109fd002
SPL ID
ae5d9540-a988-4072-9a46-b2bfcb4fd3a1
Version
1
Effective date
2012-10-15
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 01:35:47

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 8 tablets in 24 hours • with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • 3 or more alcoholic drinks every day while using this product Do not: • use with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. • use more than the recommended dose for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • when using this product do not exceed recommended dose. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product. Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever. Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

Reported adverse events (FAERS/openFDA)#

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