FDA label f19b94fe-7bea-319d-e053-2a95a90a74f0

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
248e8c14-4f50-46a4-8da4-d8edc47e5aac
SPL ID
f19b94fe-7bea-319d-e053-2a95a90a74f0
Version
4
Effective date
2023-01-06
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:49:38

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 you take more than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use: if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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 you have: heart disease high blood pressure diabetes liver disease thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if: you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. redness or swelling is present in the painful area any new symptoms appear

Reported adverse events (FAERS/openFDA)#

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