FDA label 166341fd-c187-b351-e063-6394a90aa288

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
0ce0f4af-da22-7a3d-e063-6394a90a2321
SPL ID
166341fd-c187-b351-e063-6394a90aa288
Version
4
Effective date
2024-04-18
Source export date
2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:15:54

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: Liver Warning: This product contains acetaminophen. Severe liver damage may occur if. ■ adults take more than 6 doses in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen (prescription or nonprescription) ■ adult has 3 or more alcoholic drinks while using this product. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■rash If skin reaction occurs, stop use and seek medical help right away Do not use with any other product containing acetaminophen (prescription or nonprescription), this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. WHEN USING THIS PRODUCT, DO NOT EXCEED RECOMMENDED DOSE Ask a doctor before use if you have a liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask doctor if: ■ pain gets worse or lasts more than 10 days in adults ■ 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 If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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