EZ NITE SLEEP- diphenhydramine hcl capsule, liquid filled

EZ Nite Sleep by

Drug Labeling and Warnings

EZ Nite Sleep by is a Otc medication manufactured, distributed, or labeled by Preferred Plus (Kinray). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin
• for children under 12 years of age
• with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema, or chronic bronchitis
• glaucoma
• heart disease
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep-aid.

When using this product

• drowsiness will occur
• avoid alcoholic beverages and other drugs that cause drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only one dose per day (24 hours) - see Overdose warning
• swallow whole; do not crush, chew, or dissolve
• adults & children 12 yrs & over
  • one dose=TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F) and high humidity
• protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

Preferred Plus Pharmacy® ++++

*Compare to the active ingredient in ZzzQuil®

EZ Nite Sleep

Diphenhydramine HCl 25 mg

Nighttime Sleep- Aid

Non Habit- forming

NOT FOR TREATING COLD OR FLU

SEE WARNINGS

Softgels**

**Liquid-filled capsules

KIN 211-201

Distributed by: Kinray, LLC

152-35 tenth avenue

Whitestone, NY 11357

Product of Canada

All Preferred Plus Pharmacy products are satisfaction guaranteedor your money back from retailer where purchased.

© 2014 Kinray, LLC., All Rights Reserved

PREFERRED PLUS, PREFERRED PLUS++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray LLC. All other marks are property of their respective owners. 

*This product is not manufactured or distributed by Procter & Gamble company, ZzzQuil® is a registered trademark of The Procter & Gamble company.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Product Label

Diphenhydramine HCl 25 mg

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-084
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	A41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-084-24	2 in 1 CARTON	02/12/2014	12/31/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	02/12/2014	12/31/2020

Labeler - Preferred Plus (Kinray) (012574513)