Sleepeze

Manufacturer: Medtech Products Inc.
Effective date: 2024-01-18
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:07:20

Label at a glance#

ProductSleepeze

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

Dosage and administration

Adults and children 12 years and over: ▪ take 1 tablet at bedtime if needed, or as directed by a doctor ▪ if you feel drowsy in the morning, consult a doctor or pharmacist as you may require a lower dosage (25 mg) ▪ do not take more than directed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Purpose

OTC - PURPOSE SECTION

Diphenhydramine Hydrochloride 50 mg………………..Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding

When using this product

OTC - WHEN USING SECTION

avoid drinking alcohol.

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, call a poison control centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Other information

OTHER SAFETY INFORMATION

▪ Store at 20° to 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous dibasic calcium phosphate, croscarmellose sodium, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin, water

SECURITY FEATURE: Safety sealed in individual pouches. Do not use if pouch is not safely sealed.

Important: Keep carton for future reference.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep.eze
Extra strength
Caplets
10 coated capsules

PRINCIPAL DISPLAY PANEL Sleep.eze Extra strength Caplets 10 coated capsules

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1085945	diphenhydrAMINE HCl 50 MG Oral Tablet	PSN	2
1085945	diphenhydramine hydrochloride 50 MG Oral Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63029-921-10	Sleepeze	1 in 1 CARTON	TABLET	1	2
63029-921-10	Sleepeze	10 in 1 BLISTER PACK	TABLET	10	2
63029-921-20	Sleepeze	10 in 1 BLISTER PACK	TABLET	10	2
63029-921-20	Sleepeze	2 in 1 CARTON	TABLET	2	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63029-921	SLEEPEZE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]	2	4 package rows	20240117_31d3dcb1-0898-4fee-b236-2f1096b0d787.zip

Products#

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

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

Sleepeze
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1 ALUMINUM LAKE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MINERAL OIL
MAGNESIUM STEARATE
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63029-921	63029-921-10, 63029-921-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MINERAL OIL	T5L8T28FGP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
WATER	059QF0KO0R	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
4f4da6bc-aaff-4dca-8125-ce43c053f9bc			31d3dcb1-0898-4fee-b236-2f1096b0d787	2024-01-18	Warnings	Exact identifier spl id: 4f4da6bc-aaff-4dca-8125-ce43c053f9bc spl set id: 31d3dcb1-0898-4fee-b236-2f1096b0d787

Reported adverse events (FAERS/openFDA)#

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