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EZ Nite Sleep by Safeway, Inc.

Medically reviewed on May 9, 2018

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: Safeway, Inc.
NDC Code: 21130-014

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.

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 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
  • 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 (1800-222-1222).

Directions
  • take only one dose per day (24 hours) - (see overdose warning)
  • mL=milliliter
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • adults and children 12 years and over
    • one dose=30mL 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 at 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, citrate dihydrate

Questions or comments?

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST 

Principal Display Panel

COMPARE TO ZZZQUIL® active ingredient*

Nighttime Sleep Aid

Diphenhydramine HCI 50 mg

  • Non-Habit Forming
  • Not for treating cold or flu
  • 10 % alcohol
  • See warnings

Berry Flavor

fl oz (mL)

Failure to follow these warnings could results in serious consequenses.

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 Proctor & Gamble Company.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Package Label

SIGNATURE CARE Nighttime Sleep Aid

EZ NITE SLEEP 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-014
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
PROPYLENE GLYCOL 
POLYOXYL 40 STEARATE 
WATER 
SODIUM BENZOATE 
SACCHARIN SODIUM ANHYDROUS 
TRISODIUM CITRATE DIHYDRATE 
HIGH FRUCTOSE CORN SYRUP 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
ALCOHOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-014-242 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION
1355 mL in 1 BOTTLE, PLASTIC
2NDC:21130-014-06177 mL in 1 BOTTLE, PLASTIC
3NDC:21130-014-12355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2015
Labeler - Safeway, Inc. (009137209)

 
Safeway, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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