FDA label 4765d329-ea59-4d20-e054-00144ff8d46c

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
f6ef0ee3-7e63-4f3e-8d53-9dc4fa0e6cb8
SPL ID
4765d329-ea59-4d20-e054-00144ff8d46c
Version
2
Effective date
2017-01-31
Source export date
2026-08-17
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/40383c0781ea3f73e5df32231f8b65ed8ddb390c4f71cf8c3047378d0f083484/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:05:17

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 • 3 or more alcoholic drinks daily while using this product • with other drugs containing acetaminophen Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 • diabetes • heart disease • liver disease • thyroid disease • high blood pressure • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema 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 • symptoms gets worse or last more than 5 days (children) or 7 days (adults) • you get nervous, dizzy or sleepless • redness or swelling is present • fever gets worse or lasts more than 3 days • new symptoms occur • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition