FDA label 90120c6b-e5da-48c8-8c0d-8edf43cb90a1

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
ca3d0d80-7d7e-478d-b0c2-ecc9bdb1dd1e
SPL ID
90120c6b-e5da-48c8-8c0d-8edf43cb90a1
Version
2
Effective date
2015-05-04
Source export date
2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:17

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 ■ 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 a Doctor before use if your child has liver disease Ask a Doctor/Pharmacist before use if you are 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 for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050 Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical 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.