FDA label 1970305f-005a-fa4e-e063-6394a90af144

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
35adf45c-6953-474a-9913-f25c701223ff
SPL ID
1970305f-005a-fa4e-e063-6394a90af144
Version
1
Effective date
2024-05-27
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:24:17

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 for this product With other drugs containing acetaminophen Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash. 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 non-prescription). 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 recommended dose(see overdose warning) 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 Keep out of reach of children Do not use 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

Reported adverse events (FAERS/openFDA)#

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