warnings
WARNINGS Do not use 25 MG to make a child sleepy with any other product containing diphenhydramine, even one used on skin 50 MG to make a child sleepy with any other product containing diphenhydramine, including one applied topically
FDA label 71d8e28e-5650-4821-985c-be337716ee53
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
- b5a7fa2e-d908-49b7-8441-72a692a02614
- SPL ID
- 71d8e28e-5650-4821-985c-be337716ee53
- Version
- 10
- Effective date
- 2025-09-15
- Source export date
- 2026-11-06
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 08:01:09
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 | 71d8e28e-5650-4821-985c-be337716ee53 | id | |
| spl set id | b5a7fa2e-d908-49b7-8441-72a692a02614 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.