FDA label 9c054af3-3c09-4b4d-b927-5ea83b8d6d4c

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
d1072069-f843-4c97-815f-9d4aa1d3aef3
SPL ID
9c054af3-3c09-4b4d-b927-5ea83b8d6d4c
Version
2
Effective date
2017-10-28
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:10

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 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. • to make a child sleepy • in 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. • if your child has ever had an allergic reaction to this product or any of its ingredients 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) • a breathing problem such as chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if the child is • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • do not exceed recommended dosage • excitability may occur, especially in children • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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.