FDA label 2ef5583f-2f7b-4093-a7f4-0045f9209a52

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
eb999c3c-dd4f-4d16-9f3c-b62121cdda67
SPL ID
2ef5583f-2f7b-4093-a7f4-0045f9209a52
Version
2
Effective date
2017-06-12
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:27

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. Sever liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 to make child sleepy in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if your child has glaucoma thyroid disease diabetes high blood pressure heart disease a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) liver disease Ask a doctor or pharmacist before use if your child is taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) may cause excitability, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if neverousness, dizziness or sleeplessness occur redness or swelling is present pain, nasal congestion or cough gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. Keep this and all drugs out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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