FDA.reportPublic FDA data

FDA label f008c129-7013-4cef-aad3-232bc6b16992

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
2dc10e39-6bdb-4ce1-b241-1c8aed818290
SPL ID
f008c129-7013-4cef-aad3-232bc6b16992
Version
1
Effective date
2015-07-23
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:59

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 adult takes more than 4 (30 mL each) doses in 24 hours, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning : if sore throat is sever, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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