FDA label c6a6457c-70ab-44da-93cd-5c6e8aef21c4

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
b27fa5fe-a72a-4afe-8492-8fc871e6be65
SPL ID
c6a6457c-70ab-44da-93cd-5c6e8aef21c4
Version
2
Effective date
2018-11-14
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:28

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

DO NOT USE: - with any other product containing acetaminophen - if you ever had an allergic reaction to any other pain reliever/fever reducer. ASK DOCTOR BEFORE USE if you have liver desease. ASK A DOCTOR OR PHARMACIST BEFORE USE if you are taking sedatives or tranquilizers when using this product - drowsiness will occur - avoid alcoholic drinks STOP USE AND ASK A DOCTOR IF - an allergic reaction occurs. Seek medical help right away. -new symptoms occur - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days These could be signs of a serious condition. LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 tables in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.

Reported adverse events (FAERS/openFDA)#

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