EZ NITE SLEEP NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, liquid filled 
QUALITY CHOICE (Chain Drug Marketing Association)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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

Other information

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 1-248-449-9300 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**

(**Liquid-filled capsules)

*This product is not manufactured or distributed by The Procter & Gamble Company. VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Procter & Gamble Company. 

©Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product of Canada

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

Diphenhydramine HCl 25 mg

Quality Choice EZ Sleep Softgel

 

EZ NITE SLEEP  NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code A41
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-014-484 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:63868-014-242 in 1 CARTON
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33803/11/2013
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 3/2013
Document Id: ac8f2a89-b672-489c-8675-07fefd575d7a
Set id: f85f73a2-9300-4b9b-89ab-f0d389d79c3c
Version: 5
Effective Time: 20130308
 
QUALITY CHOICE (Chain Drug Marketing Association)