FDA label 570eafa9-0344-f128-e063-6394a90a4fcb

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
5513db67-f023-7f47-e063-6294a90a2757
SPL ID
570eafa9-0344-f128-e063-6394a90a4fcb
Version
14
Effective date
2026-07-24
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:47:04

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Warnings Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours (the maximum daily amount). with other drugs containing acetaminophen Allergy alert : acetaminophen may cause severe skin reactions. symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, persists for more than 2 davs, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Keep Out of Reach of Children Overdose warning : In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Chocking hazard : Not intended for children under 3 years of age. Keep out of reach of children. Parental supervision required. 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 wafarin Drug Facts (continued) When using this product do not exceed the 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.

warnings and cautions

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours (the maximum daily amount). with other drugs containing acetaminophen Allergy alert : acetaminophen may cause severe skin reactions. symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, persists for more than 2 davs, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Keep Out of Reach of Children Overdose warning : In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Chocking hazard : Not intended for children under 3 years of age. Keep out of reach of children. Parental supervision required. 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 wafarin Drug Facts (continued) When using this product do not exceed the 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.

Reported adverse events (FAERS/openFDA)#

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