FDA label a3f0ae80-cf9a-4b6d-a678-c5ef642cd6c1

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
854833ea-1c90-4011-bd88-cfb6a61b0361
SPL ID
a3f0ae80-cf9a-4b6d-a678-c5ef642cd6c1
Version
2
Effective date
2019-12-26
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 01:48:12

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 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. Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more aloholic drinks daily while using this product Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fevere, 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) 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 nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days new symptoms occur fever gets worse, or lasts more than 3 days redness or swelling is present cough comes back, or occurs with fever, 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 recommneded dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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