FDA label bf433db9-4fdc-4f84-8d34-3c85ec1465bf

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
a23b5195-518e-4093-aea4-10ce96460ee2
SPL ID
bf433db9-4fdc-4f84-8d34-3c85ec1465bf
Version
2
Effective date
2019-04-12
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 05:37:27

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 ▪ in children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin Ask Doctor As a doctor before use if you have ▪ a breathing problem such as emphysema or chronic bronchitis ▪ glaucoma ▪ trouble urinating due to enlarged prostate gland Ask Doctor/Pharmacist As a doctor or pharmacist before use if you are taking sedatives or tranquilizers When Using When using this product ▪ avoid alcoholic drinks Stop Use Stop use and ask a doctor if sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. Pregnancy or Breast Feeding If pregnant or breast-feeding , ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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