FDA label 453a7b8d-7e1e-1dbb-e063-6294a90a7955

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
b995a0b2-898d-4a8f-b44f-097ae54e0ba5
SPL ID
453a7b8d-7e1e-1dbb-e063-6294a90a7955
Version
7
Effective date
2025-12-05
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:45

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 6 packets 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 Allergy alert: Acetaminophen may cause severe skin reactions. 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, persists 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 (MAOIs) (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. for more than 7 days for pain and 3 days for fever, unless directed by a doctor Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if taking the blood thinning drug warafin Stop use and ask a doctor if a persistent cough or symptoms do not improve within 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. new symptoms occur redness or swelling is present nervousness, dizziness, or sleeplessness occur If pregnant or breast-feeding, ask a health care professional before use. KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for 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.