FDA label ee6d2a51-0a37-4db3-8b5e-aab4a0845b18

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
bd759f58-5912-40d5-a5de-632df3e61a79
SPL ID
ee6d2a51-0a37-4db3-8b5e-aab4a0845b18
Version
2
Effective date
2021-01-19
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:52:57

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 4 doses in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily while using this product. Allergy alert: Acetaminophen may cause severe skin reaction. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 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. Ask a doctor before use if you have • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs • trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed . Stop use and ask a doctor if ▪ you get nervous, dizzy or sleepless ▪ symptoms get worse or last more than 5 days (children) or 7 days (adults) ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast- feeding ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the directed can cause serious health problem. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & children, even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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