FDA label 330c48bd-8d94-4c8f-97e1-9ff110af7ca5

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
97844d85-761a-4341-a3ef-bd33c42644d4
SPL ID
330c48bd-8d94-4c8f-97e1-9ff110af7ca5
Version
4
Effective date
2017-11-05
Source export date
2026-08-01
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/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:17:10

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 your 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 your child is • taking sedatives or tranquilizers • taking the blood thinning drug warfarin 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.