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
9f944edc-a317-4967-ae54-67b5d183591b
SPL ID
5643d078-f8b3-4654-afd2-3692a90b188d
Version
10
Effective date
2026-08-18
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:32:42
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.