FDA label 5476f4cf-4a5e-2287-e063-6394a90a5ed5

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
5476f4cf-4a5d-2287-e063-6394a90a5ed5
SPL ID
5476f4cf-4a5e-2287-e063-6394a90a5ed5
Version
1
Effective date
2026-06-17
Source export date
2026-11-06
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:50:02

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 your child takes more than 5 doses in 24 hours, wich is the maximum daily amount with other drugs containing acetaminophen Allergy alert : acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blister rash if a skin reaction occurs, stop use and seek medical help right away. 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 with any other drug containing acetaminophen (prescription or non-prescription). if your child is allergic to acetaminophen or any of the inactive ingredientes in this product Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recomended dose (see overdose warning) Stop use and ask a dctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. Keep out of reach of children Keep out of reach of children Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick 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.