SLEEPEZE MINIS- diphenhydramine hydrochloride tablet

SleepEze minis by

Drug Labeling and Warnings

SleepEze minis by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Sleepeze® 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

INGREDIENTS AND APPEARANCE

SLEEPEZE MINIS 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-926
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	S;M
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-926-16	1 in 1 CARTON	12/03/2018
1		16 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		12/03/2018

Labeler - Medtech Products Inc. (122715688)