FDA.reportPublic FDA data

FDA label e95f150e-3c74-7cb8-e053-2a95a90a9cb4

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
c0e504cd-730a-327d-e053-2a95a90aca55
SPL ID
e95f150e-3c74-7cb8-e053-2a95a90a9cb4
Version
3
Effective date
2022-09-23
Source export date
2026-08-01
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/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:06:21

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

Children's Pain Relief & Fever Reducer 160 mg / 5 mL 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 the child is allergic to acetaminophen or any other inactive ingredients in this product ____________________________________________________________________________ Ask a doctor before use if the child has liver disease ____________________________________________________________________________ Ask a doctor or pharmacist before use if the child is taking the blood thinning drug Warfarin ____________________________________________________________________________ Stop use and ask a doctor if pain gets worse or lasts more than 10 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition