FDA label 638cb598-e320-444c-9cf6-985cee5e330e

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
13bd9ea4-4534-4cb4-8057-1fa47033074a
SPL ID
638cb598-e320-444c-9cf6-985cee5e330e
Version
7
Effective date
2017-11-29
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:13:17

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. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. 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. When using this product do not exceed the recommended dosage. Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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 signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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