FDA label 3a561e67-75b5-4bc1-9c25-dd1812a9ce64

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: 30de8b4e-fe79-4de8-81b9-985c6e8be2c3
SPL ID: 3a561e67-75b5-4bc1-9c25-dd1812a9ce64
Version: 10
Effective date: 2023-11-20
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:38:51

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		3a561e67-75b5-4bc1-9c25-dd1812a9ce64	id
spl set id		30de8b4e-fe79-4de8-81b9-985c6e8be2c3	set_id

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 – to make a child sleepy – with any other products containing diphenhydramine, including one applied topically Ask a doctor before use if you have –glaucoma -a breathing problem such as emphysema or chronic bronchitis –difficulty in urination due to enlargement of the prostate gland This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. DO NOT USE IF BLISTER UNIT IS BROKEN

Reported adverse events (FAERS/openFDA)#

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