FDA label a547b9c9-3ca2-4065-8d71-c55ea5ab6c9a

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
d67e31b0-5d5b-4a51-b088-31f70cdfbcdd
SPL ID
a547b9c9-3ca2-4065-8d71-c55ea5ab6c9a
Version
3
Effective date
2018-04-23
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:02:21

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 This package is intended for institutional use only. If pregnant or breast-feeding, ask a health professional before use. This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized. TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister is torn or broken. Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount • child takes more that 5 doses in 24 hours. • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks everyday while using this product Ask a doctor before use if the user has liver disease. 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 or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if • pain gets worse or lasts more than 10 days in adults and children • pain gets worse or lasts more than 5 days in children under 12 years • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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