SLEEPEZE- diphenhydramine hydrochloride tablet 
Medtech Products Inc.

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SleepEze Caplet 50 mg_Export only 63029-921

Drug Facts

Active ingredient (in each tablet)

Purpose

Diphenhydramine Hydrochloride 50 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 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

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

SECURITY FEATURE: Safety sealed in individual pouches. Do not use if pouch is not safely sealed.

Important: Keep carton for future reference.

PRINCIPAL DISPLAY PANEL

Sleep.eze
Extra strength

Caplets

10 coated capsules

PRINCIPAL DISPLAY PANEL
Sleep.eze
Extra strength
Caplets
10 coated capsules

SLEEPEZE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-921
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
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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code S;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-921-101 in 1 CARTON05/23/2012
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63029-921-202 in 1 CARTON05/23/2012
210 in 1 BLISTER PACK; 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: 4f4da6bc-aaff-4dca-8125-ce43c053f9bc
Set id: 31d3dcb1-0898-4fee-b236-2f1096b0d787
Version: 2
Effective Time: 20240118
 
Medtech Products Inc.