FDA label f9dd374c-214e-416b-9777-a31567fd887f

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
e07ea561-9afe-40c7-8f3a-cfe228282a45
SPL ID
f9dd374c-214e-416b-9777-a31567fd887f
Version
2
Effective date
2018-04-23
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:22:57

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. Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Do not use with any other product containing acetaminophen. Stop use and ask a doctor if new symptoms occur, redness or swelling is present, pain gets worse or lasts for more than 10 days or fever gets worse or last more than 3 days. 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. TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister is torn or broken. This unit dose package is not child-resistant. If dispensed for outpatient use, a child resistant container should be utilized.

Reported adverse events (FAERS/openFDA)#

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