SLEEPEZE GELCAPS- diphenhydramine hydrochloride capsule, gelatin coated

Sleepeze Gelcaps by

Drug Labeling and Warnings

Sleepeze Gelcaps 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 (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

Sleepeze® MD
extra strength
gelcaps
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 50 mg
20 soft gel capsules

DIN 02238644

INGREDIENTS AND APPEARANCE

SLEEPEZE GELCAPS 
diphenhydramine hydrochloride capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-927
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
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
Color	blue	Score	no score
Shape	OVAL	Size	1mm
Flavor		Imprint Code	P50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-927-20	1 in 1 CARTON	05/23/2012
1		10 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		05/23/2012

Labeler - Medtech Products Inc. (122715688)