FDA label 2b4dce65-2fd4-b39d-e063-6294a90a95ea
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
- SPL set ID
- 2489c555-eeeb-f201-e063-6294a90a3b09
- SPL ID
- 2b4dce65-2fd4-b39d-e063-6294a90a95ea
- Version
- 2
- Effective date
- 2025-01-09
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:26:08
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 2b4dce65-2fd4-b39d-e063-6294a90a95ea | id | |
| spl set id | 2489c555-eeeb-f201-e063-6294a90a3b09 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS AND PRECAUTIONS Consult a licensed healthcare practitioner before starting melatonin, especially if the child has a medical condition or is taking other medications. Melatonin may cause daytime drowsiness, so ensure that the child avoids activities requiring alertness, such as riding a bike or climbing, after taking melatonin. Discontinue use and seek medical advice if any adverse reactions occur.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Possible adverse reactions include daytime drowsiness, headaches, dizziness, gastrointestinal issues such as nausea or stomach cramps, and mood changes like irritability or agitation. Allergic reactions, although rare, may include rash, itching, swelling, or difficulty breathing. The potential impact on hormonal development, particularly puberty, is not well understood, so long-term use should be monitored.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.