FDA label 609466d0-bcd9-4c69-bb7c-ef119fa7a83c

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
40033873-4d75-407d-a9a4-851216178c0e
SPL ID
609466d0-bcd9-4c69-bb7c-ef119fa7a83c
Version
4
Effective date
2024-10-09
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:55:29

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: These products contain acetaminophen. Severe liver damage may occur if you take more than 6 doses in 24 hours (Night-Time), which is the maximum daily amount more than 6 doses in 24 hours (Day-Time), which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using these products Sore throat warning : If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, rash, nausea, or vomiting, consult a doctor promptly. Overdose warning : Taking more than the recommended dose (overdose) could cause serious health problems . 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 children even if you do not notice any signs or symptoms Do not use with other drugs 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 using if you have liver disease heart disease asthma emphysema thyroid disease diabetes high blood pressure cough with excessive phlegm (mucus) breathing problems chronic bronchitis persistent or chronic cough cough associated with smoking trouble urinating due to enlarged prostate gland glaucoma (Night-Time only) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed, in addition when using Night-Time: excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness do not use with other products containing acetaminophen Stop use and ask a doctor if swelling or redness is present symptoms do not get better within 7 days or are accompanied by a fever you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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