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
NIGHTTIME SLEEP AID
Manufacturer
Allegiant Health
Product type
HUMAN OTC DRUG
SPL set ID
88feea1d-c961-45e9-b9a6-1418b970aaba
SPL ID
88fee002-990d-4311-a3a6-2f8ed1fb6579
Version
3
Effective date
2024-01-16
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:54:15
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 Do not use n for children under 12 years of age. with any other product containing diphenhydramine, even one used on skin with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products Ask a doctor before use if heart disease trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as asthma, emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid When using this product do not use more than directed avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breastfeeding, 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.