FDA label ebb8ddde-654f-4348-9797-6acb4427be34

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
ac147fc9-d772-4d58-be39-aa1448e7dcd1
SPL ID
ebb8ddde-654f-4348-9797-6acb4427be34
Version
11
Effective date
2018-11-15
Source export date
2026-11-06
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/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:40:42

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 • 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. Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative. When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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