FDA label 86cead9a-caed-751e-e053-2a91aa0a1a50

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
86cefd91-771f-e4e7-e053-2991aa0a655e
SPL ID
86cead9a-caed-751e-e053-2a91aa0a1a50
Version
1
Effective date
2019-04-18
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:29:44

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, which is the maximum daily amount. With other drugs containing acetaminophen. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddining Blisters Rash If 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. Do not use : With any other products containing acetaminophen, (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If your child is allergic to acetaminophen or any of the inactive ingredients in this product. When using this product, DO NOT EXCEED RECOMMENDED DOSAGE (see overdose warning). Stop use and ask a doctor if: New symptoms occur. Fever gets worse or lasts more than 3 days. Pain gets worse or lasts more than 5 days. Redness or swelling is present. These could be signs of a serious condition. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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