Sleepeze eze melts

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 00:07:21

Label at a glance#

ProductSleepeze eze melts

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure11 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 or 2 tablets at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, reduce dose to 1 tablet ▪do not take more than directed

Contacts and useful links#

PhoneLabel contact1-800-443-4908

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

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

●Adults and children 12 years and over: ▪take 1 or 2 tablets at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, reduce dose to 1 tablet

▪do not take more than directed

Other information

OTHER SAFETY INFORMATION

▪ Store at 20° to 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, d&c red 7 lake, ethylcellulose, flavour, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, stearic acid, sucralose, sucrose

Questions?

OTC - QUESTIONS SECTION

1-800-443-4908

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep.eze
25 mg Diphenhydramine Hydrochloride Tablets
16 dissolving tablets

PRINCIPAL DISPLAY PANEL Sleep.eze 25 mg Diphenhydramine Hydrochloride Tablets 16 dissolving tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	2
1049630	diphenhydramine hydrochloride 25 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	Strength	SPL version
63029-925-16	Sleepeze eze melts	1 in 1 CARTON	TABLET	1		2
63029-925-16	Sleepeze eze melts	8 in 1 BLISTER PACK	TABLET	8		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63029-925	SLEEPEZE EZE MELTS (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]	2	2 package rows	20240117_685cae75-a977-4028-8414-8ea56f3be06e.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Sleepeze eze melts
Diphenhydramine Hydrochloride
DIPHENHYDRAMINE
CITRIC ACID MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
ETHYLCELLULOSES
D&C RED NO. 7
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MINERAL OIL
MAGNESIUM STEARATE
MANNITOL
STEARIC ACID
POVIDONE
SUCRALOSE
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63029-925	63029-925-16

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
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ETHYLCELLULOSES	7Z8S9VYZ4B	IACT
D&C RED NO. 7	ECW0LZ41X8	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MINERAL OIL	T5L8T28FGP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
POVIDONE	FZ989GH94E	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SUCROSE	C151H8M554	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
d2a6e2e4-c9db-4071-a60e-0c3bcb55fcab			685cae75-a977-4028-8414-8ea56f3be06e	2024-01-18	Warnings	Exact identifier spl id: d2a6e2e4-c9db-4071-a60e-0c3bcb55fcab spl set id: 685cae75-a977-4028-8414-8ea56f3be06e

Reported adverse events (FAERS/openFDA)#

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