Sleep Aid

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)

Brand name
Sleep Aid
Generic name
DIPHENHYDRAMINE HCL 25 MG
Manufacturer
Allegiant Health
Product type
HUMAN OTC DRUG
SPL set ID
dbbc535f-515a-4d9b-b799-34e60f5230bb
SPL ID
b9e7a97b-a3e9-427c-8cc5-9c94941409a1
Version
7
Effective date
2018-12-21
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:44:38
Harmonized routes table
Harmonized routes
ORAL

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 products containing diphenhydramine, including ones used on skin Ask doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask Doctor or Pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic beverages drowsiness may occur do not drive a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnancy 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.