SLEEPEZE EZE MELTS- diphenhydramine hydrochloride tablet 
Medtech Products Inc.

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SleepEze eze melts_Export only 63029-925-16

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine Hydrochloride 25 mg

Purpose

Nighttime sleep aid

Uses

● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

Warnings

Do not use

●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

●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

avoid drinking alcohol.

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

●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

 Store at 20° to 25°C

Inactive ingredients

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

Questions?

1-800-443-4908

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

SLEEPEZE EZE MELTS 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-925
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MINERAL OIL (UNII: T5L8T28FGP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize13mm
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-925-161 in 1 CARTON08/03/2010
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/03/2010
Labeler - Medtech Products Inc. (122715688)

Revised: 1/2024
Document Id: d2a6e2e4-c9db-4071-a60e-0c3bcb55fcab
Set id: 685cae75-a977-4028-8414-8ea56f3be06e
Version: 2
Effective Time: 20240118
 
Medtech Products Inc.