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 adults and children 12 years and over: take 1 capsule at bedtime if needed, or as directed by a doctor children under 12 years: do not use

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from light, heat and moisture see end flap for expiration date and lot number

Contacts and useful links#

PhoneLabel contact1-800-426-9391

Websitewww.discount-drugmart.com

www.discount-drugmart.com

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
adults and children 12 years and over: take 1 capsule at bedtime if needed, or as directed by a doctor
children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from light, heat and moisture
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug
mart
FOOD FAIR

NDC 53943-928-91

May Contain
Anti-Theft
Device

Sleep Aid

Diphenhydramine HCl 50 mg
Nighttime Sleep-Aid

*Compare to the active ingredient in Unisom® SleepGels®

Non-habit forming

Actual Size

64 Softgels

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Unisom® SleepGels®.

50844 ORG012072891

Product of Dubai
Packaged and Quality Assured in the USA

SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART
211 COMMERCE DRIVE, MEDINA, OHIO 44256

DISTRIBUTED BY: DRUG MART - FOOD FAIR
211 COMMERCE DRIVE, MEDINA, OH 44256
www.discount-drugmart.com

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1020477	diphenhydrAMINE (Oral Pill)	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD Active

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Sleep Aid
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
GLYCERIN
ISOPROPYL ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
WATER
SORBITOL
SORBITAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53943-928	53943-928-27, 53943-928-91

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	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
3c9a2490-2369-44e3-b8fb-d8f9b04f827e			68b1cb16-037e-46f7-9c1f-8ff728031356	2022-11-19	Warnings	Exact identifier spl id: 3c9a2490-2369-44e3-b8fb-d8f9b04f827e spl set id: 68b1cb16-037e-46f7-9c1f-8ff728031356

Reported adverse events (FAERS/openFDA)#

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

Sleep Aid