SLEEPEZE- diphenhydramine hydrochloride tablet 
Medtech Products Inc.

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SleepEze Caplet 25 mg_Export only 63029-920

Drug Facts

Active ingredient (in each tablet)

Purpose

Diphenhydramine Hydrochloride 25 mg………………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

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

Questions?

1-800-443-4908

PRINCIPAL DISPLAY PANEL

Sleep.eze

Regular Strength
Caplets
Diphenhydramine Hydrochloride Tablets 25 mg

20 coated caplets

PRINCIPAL DISPLAY PANEL
Sleep.eze

Regular Strength
Caplets
Diphenhydramine Hydrochloride Tablets 25 mg 
20 coated caplets

SLEEPEZE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-920
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MINERAL OIL (UNII: T5L8T28FGP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize10mm
FlavorImprint Code S;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-920-202 in 1 CARTON05/24/2012
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/24/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 1/2024
Document Id: d3a12906-d2fa-4ce3-9123-4eae4a435748
Set id: e4794600-9b15-4dad-a605-d6c2841ff375
Version: 2
Effective Time: 20240112
 
Medtech Products Inc.