SLEEPEZE MINIS- diphenhydramine hydrochloride tablet 
Medtech Products Inc.

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SleepEze 50 mg Minis_Export only 63029-926-16

Drug Facts

Active ingredient

Purpose

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

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 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

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® MD

extra strength minis

DIPHENHYDRAMINE HYDROCHLORIDE TABLETS USP 50 mg

extra fort

DIPHÉNHYDRAMINE CHLORHYDRATE EN COMPRIMÉ USP 50 mg

nighttime sleep aid / la solution contre insomnie

16 coated tablets/ comprimes enrobes

DIN 02478757

PRINCIPAL DISPLAY PANEL

Sleep•eze® MD
extra strength minis
DIPHENHYDRAMINE HYDROCHLORIDE TABLETS USP 50 mg

extra fort
DIPHÉNHYDRAMINE CHLORHYDRATE EN COMPRIMÉ USP 50 mg
nighttime sleep aid / la solution contre insomnie

16 coated tablets/ comprimes enrobes


DIN 02478757

SLEEPEZE MINIS 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-926
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize8mm
FlavorImprint Code S;M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-926-161 in 1 CARTON12/03/2018
116 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/03/2018
Labeler - Medtech Products Inc. (122715688)

Revised: 1/2024
Document Id: 746c4560-b583-44a1-a6f3-594435d4244e
Set id: 16f9b5f4-c116-4f1d-9063-be3abb8ac9ee
Version: 2
Effective Time: 20240118
 
Medtech Products Inc.