CHILDRENS ACETAMINOPHEN

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)

Brand name
CHILDRENS ACETAMINOPHEN
Generic name
CHILDRENS ACETAMINOPHEN ORAL
Manufacturer
AARNA USA INC.
Product type
HUMAN OTC DRUG
SPL set ID
38070d15-2678-4e59-e063-6294a90ab690
SPL ID
38070d2d-e016-7d5c-e063-6394a90a71ac
Version
1
Effective date
2025-06-20
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:37:32
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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 then 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: A cetaminophen 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, persist or 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 anyof the inactive ingredients in this product. Ask a doctor or pharmacist before use if the child has liver disease. Ask 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 for more then 5 days fever gets worse or last for more then 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. Overdose warning: In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms. Keep out of Reach of children

Reported adverse events (FAERS/openFDA)#

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