CVS Health 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
CVS Health Nighttime Sleep-Aid
Generic name
DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
CVS Pharmacy,Inc.
Product type
HUMAN OTC DRUG
SPL set ID
e8785ba8-e53e-491e-bbfe-04e860f36131
SPL ID
0d0290a4-671f-43f0-acb8-eec3b084a99c
Version
9
Effective date
2026-08-18
Source export date
2026-09-28
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:41:31
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use ▪ for children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin ▪ with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have ▪ a breathing problem such as asthma, emphysema, or chronic bronchitis ▪ glaucoma ▪ difficulty in urination due to enlargement of the prostate gland ▪ heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid. When using this product ▪ avoid alcoholic beverages and other drugs that cause drowsiness ▪ drowsiness will occur ▪ be careful when driving a motor vehicle or operating 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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.1-800-222-1222

Reported adverse events (FAERS/openFDA)#

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