Sleep Aid

Manufacturer: CVS Pharmacy | LNK International, Inc.
Effective date: 2020-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 23:13:20

Label at a glance#

ProductSleep Aid Nighttime

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 mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. take only one dose per day (24 hours) adults and children 12 years and over: take 30 mL (2 TBSP) in dosing cup provided at bedtime if needed or as directed by a doctor children under 12 years: do not use

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

Label contents#

Full prescribing information#

Active ingredient(in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
take only one dose per day (24 hours)
adults and children 12 years and over: take 30 mL (2 TBSP) in dosing cup provided at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Other information

SPL UNCLASSIFIED SECTION

each 30 mL dose cup contains: sodium 17 mg
store at 25ºC (77ºF); excursions permitted between 15º-30º C (59º-86ºF)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

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*

Alcohol Free
Nighttime

Sleep Aid
DIPHENHYDRAMINE HCl 50 mg

Nighttime Sleep Aid

Non-habit forming

Not for treating cold or flu

Berry Flavor

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® ZzzQuil™ Nighttime Sleep Aid.

50844 ORG101700245

V-11112

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Sleep Aid Nighttime
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
SUCRALOSE
SUCROSE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-208	69842-208-96, 69842-208-02, 69842-208-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SUCROSE	C151H8M554	IACT
XANTHAN GUM	TTV12P4NEE	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
5d37462a-7067-461e-ac1f-5d7d3aaac2e7			1a862c79-e57a-4a17-8ffc-f8a0b802d3c1	2021-02-22	Warnings	Exact identifier spl set id: 1a862c79-e57a-4a17-8ffc-f8a0b802d3c1

Reported adverse events (FAERS/openFDA)#

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