FDA label bcc9cfa8-58ea-4321-8b8a-25a109a7de3c

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: fa4c39ef-797d-4acb-996d-ddf2aa09ca3d
SPL ID: bcc9cfa8-58ea-4321-8b8a-25a109a7de3c
Version: 4
Effective date: 2018-05-15
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

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		bcc9cfa8-58ea-4321-8b8a-25a109a7de3c	id
spl set id		fa4c39ef-797d-4acb-996d-ddf2aa09ca3d	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 TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Do not use ￭to make a child sleepy ￭with any other product containing diphendydramine, even one used on skin Ask a doctor before use if you have ￭glaucoma ￭a breathing problem such as emphysema or chronic bronchitis ￭trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product ￭marked drowsiness may occur. ￭avoid alcoholic drinks ￭alcohol, sedatives, and tranquilizers may increase drowsiness ￭be careful when driving a motor vehicle or operating machinery ￭excitability may occur, especially in children

Reported adverse events (FAERS/openFDA)#

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