Sleep Aid

Manufacturer: CVS PHARMACY | LNK International, Inc.
Effective date: 2022-05-18
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:01:02

Label at a glance#

ProductSleep Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

do not take more than directed take only one dose per day (24 hours) adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor children under 12 years: do not use

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from light see end flap for expiration date and lot number store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat above 40ºC (104ºF) and high humidity

Contacts and useful links#

PhoneLabel contact1-800-426-9391

PhoneLabel contact1-800-SHOP CVS

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

avoid alcoholic beverages.

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
take only one dose per day (24 hours)
adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
protect from light
see end flap for expiration date and lot number
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid excessive heat above 40ºC (104ºF) and high humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health®

Compare to the active ingredient in Vicks® ZzzQuil® NIGHTTIME SLEEP-AID LiquiCaps®*

Nighttime
Sleep-Aid
DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid
Non-habit forming

Not for treating pain,
cold or flu

48 LIQUID-FILLED CAPSULES

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® NIGHTTIME SLEEP-AID LiquiCaps®.

50844 ORG031965422

Product of China
Packaged and Quality
Assured in the USA
V-11112

CVS® Quality
Money Back Guarantee

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Sleep Aid
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-654	69842-654-22, 69842-654-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5d593b6c-8b18-49ec-af8d-0ff210cb6abd			d0e4a444-e3d7-4bc4-88d8-def8eab7dbff	2022-05-18	Warnings	Exact identifier spl id: 5d593b6c-8b18-49ec-af8d-0ff210cb6abd spl set id: d0e4a444-e3d7-4bc4-88d8-def8eab7dbff

Reported adverse events (FAERS/openFDA)#

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