Nighttime 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
Nighttime Sleep-aid
Generic name
DIPHENHYDRAMINE HCL
Manufacturer
NORTHEAST PHARMA
Product type
HUMAN OTC DRUG
SPL set ID
d2062094-d1b5-38ab-e053-2995a90a5670
SPL ID
352f4b78-30e7-e864-e063-6394a90a8ace
Version
3
Effective date
2025-05-15
Source export date
2026-08-17
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/f2a007a22a89560a66943d28521709913d039c2d0cd7e278faf1082cd194c72c/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:16:33
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 • with any other product containing diphenhydramine, including one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema, asthma, or chronic bronchitis • glaucoma • 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 produc t • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. 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.