FDA label aa2ce06b-89bd-b998-e053-2995a90a834a

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
aa2ce06b-89bc-b998-e053-2995a90a834a
SPL ID
aa2ce06b-89bd-b998-e053-2995a90a834a
Version
1
Effective date
2020-07-11
Source export date
2026-11-06
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/2026-11-06/7dfa569f2d8f065241260fd9a4886d0ef0a3120fd6ee31d6d07c234e689e8c91/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 08:18:56

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 - for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness

Reported adverse events (FAERS/openFDA)#

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