FDA label 0ea9a1fd-e7b3-4b85-b1d5-bb35858cd231

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
fc499d20-3c05-43f6-875c-3a3474df03ce
SPL ID
0ea9a1fd-e7b3-4b85-b1d5-bb35858cd231
Version
3
Effective date
2020-04-28
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:25

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: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place. Not to be taken by pregnant or lactating women . If you are taking MAO inhibitors, immunosuppressant drugs, anti-coagulation therapy, or anti-hypertensive medication, or have an autoimmune, seizure, psychiatric or depressive disorder consult your healthcare professional before using this product. Long-term use of melatonin has not been studied. May cause drowsiness. Do not use before or while operating a motor vehicle or heavy machinery.

Reported adverse events (FAERS/openFDA)#

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