EZ NITE SLEEP NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, liquid filled

EZ Nite Sleep by

Drug Labeling and Warnings

EZ Nite Sleep by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). 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 a 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

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol*, purified water, sorbitan, sorbitol

*may contain this ingredient

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in ZZZQUIL®

EZ Nite Sleep

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Non Habit-Forming

Not for Treating Cold or Flu | See Warnings

Softgels

†This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company. 

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Failure to follow these warnings could result in serious consequences.

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

Quality Choice EZ Nite Sleep Softgels

 

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP  NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-248
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 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	A41;602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-248-24	24 in 1 CARTON	07/31/2014	12/31/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63868-248-48	48 in 1 CARTON	07/31/2014	12/31/2020
2		1 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	07/31/2014	12/31/2020

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)