FDA label 46901730-77f6-35bd-e063-6394a90ae9ff

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
0d9c3add-8083-42b4-ac06-f3a323b61955
SPL ID
46901730-77f6-35bd-e063-6394a90ae9ff
Version
3
Effective date
2025-12-22
Source export date
2026-08-08
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/8e6fb5103b1ab4ab5de5645b4a27f29a2c2739cd9369b81b7befcfa3734d8ef4/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:42:10

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

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. Ask a doctor before use if user has: liver disease Ask a doctor or pharmacist before use if: the user is taking the blood thinnig drug warfarin. Stop use and ask a doctor if: Symptoms do not improve. Pain gets worse or lasts for more than 10 days. Fever gets worse or lasts for more than 3 days. New symptoms occur. Redness or swelling is present. A rare sensitivity reaction occurs. You may report side effects to 1-888-952-0050 If pregnant or breast-feeding, ask a health professional before use. Do not exceed recommended daily dosage.