FDA label c0c8e3f6-2940-4c0e-9c63-350dc0be5c53

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
5017f066-5642-44df-b57b-a827e7dd4f20
SPL ID
c0c8e3f6-2940-4c0e-9c63-350dc0be5c53
Version
1
Effective date
2020-12-23
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 02:23:46

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. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Sever liver damage may occur if you take more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyd ay while using this product Allergy alert: acetaminophen may cause sever skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek mdical help right away. 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 thris product. Ask a doctor before use if you have liver disease Ask a doctor before use if you are taking the blodd thinning drug warfarin. When using this product: Do not exceed recomended dose. Stop use and ask a doctor if: pain gets worse or lasts more than 10 days 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.

Reported adverse events (FAERS/openFDA)#

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