FDA label f19b1b4c-e726-530e-e053-2a95a90a4c29

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
653ed8ac-102b-40e7-8fa7-af3b66bf1b26
SPL ID
f19b1b4c-e726-530e-e053-2a95a90a4c29
Version
4
Effective date
2023-01-06
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:52:30

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: Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor promptly. Drug Interaction Precaution: 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. Do not use: if using any other product containing any of the above active ingredients or with other acetaminophen products, this will provide more than the recommended dose (overdose) and could cause serious health concerns Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage. Stop use and ask a doctor if: • new symptoms occur • redness or swelling is present • pain gets worse or lasts for more than 7 days • fever gets worse or lasts for more than 3 days • nervousness, dizziness or sleeplessness occur

Reported adverse events (FAERS/openFDA)#

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