FDA label 40290cf7-9a09-177a-e054-00144ff88e88

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
cd724883-eb54-401e-846a-ab28f69e4141
SPL ID
40290cf7-9a09-177a-e054-00144ff88e88
Version
2
Effective date
2016-10-31
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:26

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 DO NOT USE •with any other product containing acetaminophen • for more than 3 days for fever unless directed by a doctor • for more than 5 days for pain unless directed by a doctor Stop Use and Ask a Doctor If: • symptoms do not improve • new symptoms occur· pain or fever persists or gets worse • redness or swelling is present· sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting Do not exceed recommended dose: Taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems. Keep this and all drugs out of the reachof children. In case of accidental overdose, contact a physician or Posion Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms TAMPER-EVIDENT BOTTLE CAP. DO NO USE IF OUTER SEAL (IMPRINT:"SEALED FOR YOUR PROTECTION") IS MISSING OR BROKEN. This product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Children's Tylenol Elixir.

Reported adverse events (FAERS/openFDA)#

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