FDA label 47681aee-01d3-42f5-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
8b9a8981-38f8-4b5d-bfc3-6072e7bc38ed
SPL ID
47681aee-01d3-42f5-e054-00144ff8d46c
Version
2
Effective date
2017-01-31
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:33

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 with other drugs containing acetaminophen 3 or mote alcoholic drinks daily 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. 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 Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedative or tranquilizers When using this product do not use more than directed. excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery marked drowsiness may occur avoid alcoholic beverages Stop use and ask a doctor if new symptoms occur redness or swelling is present symptoms do not improve within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days you get nervous, dizzy or sleepless

Reported adverse events (FAERS/openFDA)#

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