FDA label b91b99bd-65ab-4ec7-ab48-1b925e13c197

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
c8dea1e9-95d2-468d-9126-7400c92dc44f
SPL ID
b91b99bd-65ab-4ec7-ab48-1b925e13c197
Version
3
Effective date
2010-10-07
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:34:46

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 12 tablets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor with any other drug using the above active ingredients 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 thyroid disease diabetes high blood pressure heart disease glaucoma chronic bronchitis or emphysema difficulty in urination due to enlargement of the prostate gland When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers Stop use and ask a doctor if symptoms do not improve within 7 days or are accompanied by a fever pain or fever persists or gets worse redness or swelling is present any new symptoms appear Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of 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.