FDA label 155ca669-a441-9c2a-e063-6394a90a5a99

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
dd4202b4-cbff-64b9-e053-2995a90aeb97
SPL ID
155ca669-a441-9c2a-e063-6394a90a5a99
Version
4
Effective date
2024-04-05
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:46

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 acetaminaphen Allergy warning Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blister rash If skin reaction occurs, stop use and seek medical help right away. Sore throat warning If sore throat is severe, persists more than 2 days, is accompained or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly. Do not use with any other drug containing aceptaminophen (prescription or nonprescription). I f you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the child has liver disease heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur redness or swelling is present pain, nasal congestion or cough gets worse or lasts more than 5 days new symptoms occur fever gets worse or lasts more than 3 days cough comes back, or occurs with rash or headache that lasts These could be signs of a serious condition. Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any sings or symptoms. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any sings or symptoms.

Reported adverse events (FAERS/openFDA)#

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