FDA label f7cedd09-39f0-4e3c-a6e6-d8b00da2075e

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
bfae4ae0-71f0-4ad7-97b2-84498ec6a41b
SPL ID
f7cedd09-39f0-4e3c-a6e6-d8b00da2075e
Version
1
Effective date
2012-10-15
Source export date
2026-11-06
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:28:12

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, 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: • pain gets worse or lasts for more than 10 days • a rare sensitivity reaction occurs • fever gets worse or lasts more than 3 days • symptoms do not improve • new symptoms occur • redness or swelling is present. You may report side effects to 888-952-0050.

Reported adverse events (FAERS/openFDA)#

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