FDA label 158f7716-2b9a-42f1-be9a-d9652258301f

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
3e6822a7-58ff-4778-a24e-7d9e8ecb1d33
SPL ID
158f7716-2b9a-42f1-be9a-d9652258301f
Version
1
Effective date
2015-08-10
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:33:37

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 • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product Precaution: If a rare sensitivity reaction occurs, the drug should be discontinued. 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. • for more than 10 days for pain unless directed by a doctor than 3 days unless directed by a doctor when using this product do not exceed recommended dose Stop use and ask a doctor if: symptoms do not improve new symptoms occur pain gets worse or lasts for more than 10 days redness or swelling is present

Reported adverse events (FAERS/openFDA)#

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