EZ NITE SLEEP- diphenhydramine hcl liquid 
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 30 mL)

Diphenhydramine HCl 50 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 the skin
  • in children under 12 years of age


Ask a doctor before use if you have

  • glaucoma
  • breathing problem such as occurs with asthma or emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages.

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • take only one dose per day (24 hours)
  • mL=milliliter
  • keep dosing cup with product
  • measure only with dosing cup provided. Do not use any other dosing device.
  • adults and children 12 years and over
    • one dose = 30 mL at bedtime if needed, or as directed by a doctor
  • children under 12 years do not use 

Other information

  • each 30 mL contains: sodium 23 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light

Inactive ingredients

citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate

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 HCI 50 mg

Non-Habit Forming

Not for Treating Cold or Flu

Alcohol 10%

Berry Flavor

fl oz (mL)

failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

*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 9 Mile Rd

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

Diphenhydramine HCI 50 mg

QUALITY CHOICE EZ Nite Sleep

EZ NITE SLEEP 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-016-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201512/30/2022
2NDC:63868-016-13355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201512/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201512/30/2022
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 11/2020
Document Id: d59484ea-0ad7-4c8a-bd91-93863a942595
Set id: 24046e5a-79f3-49d6-b62b-ca1287d7c20f
Version: 4
Effective Time: 20201130
 
QUALITY CHOICE (Chain Drug Marketing Association)