SLEEPEZE GELCAPS- diphenhydramine hydrochloride capsule, gelatin coated 
Medtech Products Inc.

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SleepEze Gelcaps 50 mg_Export only 63029-927-20

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine Hydrochloride 50 mg

Purpose

Nighttime sleep aid

Uses

● relieves occasional sleeplessness

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 capsule 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

Other information

Store at 20° to 25°C

Inactive ingredients

FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, sorbitan, sorbitol, water

Questions?

1-800-443-4908

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PRINCIPAL DISPLAY PANEL

Sleep•eze® MD
extra strength
gelcaps
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 50 mg
20 soft gel capsules

DIN 02238644

Sleep•eze® MD
extra strength 
Gel Caps
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 50 mg
20 soft gel capsules


DIN 02238644

SLEEPEZE GELCAPS 
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-927
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize1mm
FlavorImprint Code P50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-927-201 in 1 CARTON05/23/2012
110 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/23/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 1/2024
Document Id: 1d2e3ef9-ecfe-4971-9904-84a2ee24167e
Set id: 2ff54df4-2fb8-4d9d-a363-316c9885f713
Version: 2
Effective Time: 20240118
 
Medtech Products Inc.