FDA label d74096c4-6b78-4325-ab71-6f46dede4375

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
bc49b6e4-9ff6-424f-b7a6-3456c325148a
SPL ID
d74096c4-6b78-4325-ab71-6f46dede4375
Version
11
Effective date
2020-05-19
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:17

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 Warnings See New Warnings Information 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 than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 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. ■ If you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if the user has liver disease. 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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