FDA label 1d0151fa-01e3-4cfa-9e7e-86e31ecfd8c4

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
de9c6c1d-ff69-49c2-8c18-2a556d229836
SPL ID
1d0151fa-01e3-4cfa-9e7e-86e31ecfd8c4
Version
2
Effective date
2019-01-30
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:00:35

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 adult/child takes More than 4 doses in 24 hours, which is the maximum daily amount for this product. With other drugs containing acetaminophen. Adult has 3 or more alcoholic drinks every day while using this product. 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 (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. To make a child sleep. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING. Ask a doctor before use if you have Glaucoma Liver disease Heart disease High blood pressure Thyroid disease Diabetes Trouble urinating due to an enlarged prostate gland Persistent or chronic cough such as occurs with smoking, asthma or emphysema Cough that occurs with too much phlegm (mucus) A sodium restricted diet Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizers Taking the blood thinning drug warfarin

Reported adverse events (FAERS/openFDA)#

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