FDA label 49a27970-f498-934d-e063-6394a90a08d9

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
49a27970-f497-934d-e063-6394a90a08d9
SPL ID
49a27970-f498-934d-e063-6394a90a08d9
Version
1
Effective date
2026-01-30
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:01:44

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 redding Blisters 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 nonprescription). 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. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfaron. When using this product do not exceed recommended dosage. Ask a doctor before use if your child has liver disease. Stop use and ask a doctor if Pain gets worse or lasts more than 5 days Fever gets worse or lasts more the 3 days New symptoms occur Redness or swelling is present. These could be signs of a serious condition. Keep out of reach of children. Keep out of reach of children. In case of overdose, get medical help or contact a Posin Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symtoms.

Reported adverse events (FAERS/openFDA)#

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