FDA label 4b8f9647-8697-4553-96da-2efba30f0cf3

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
125e418a-6538-401c-a67f-58425c55a2da
SPL ID
4b8f9647-8697-4553-96da-2efba30f0cf3
Version
2
Effective date
2018-12-20
Source export date
2026-10-12
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/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:39

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 4 doses in 24 hours, which is the maximum daily amount with any other drugs containing acetaminophen 3 or more alcoholic drinks every day while using these 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. Ask a doctor before using if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis (Nighttime Sinus only) glaucoma (Nighttime Sinus only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed, in addition when using Nighttime Sinus: 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 Stop use and ask a doctor if redness or swelling 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 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. Overdose warning : Taking more than the recommended dose 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.

Reported adverse events (FAERS/openFDA)#

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