FDA label fc3d9754-8aa8-47cd-9a5a-13c1f7589294

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
fc3d9754-8aa8-47cd-9a5a-13c1f7589294
SPL ID
fc3d9754-8aa8-47cd-9a5a-13c1f7589294
Version
1
Effective date
2015-03-03
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:33:59

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 3 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 taken 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask doctor before use if your child has liver disease Ask doctor or pharmacist before use if the user is taking the blood thinning drug warfarin When using this product do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems Stop use and ask a doctor if symptoms do not improve pain gets worse or lasts more than 5 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present You may report side effects to 888-952-0050

warnings and cautions

Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen

warnings and cautions

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

Reported adverse events (FAERS/openFDA)#

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