Label: EZ NITE SLEEP- diphenhydramine hcl liquid

  • NDC Code(s): 21130-014-06, 21130-014-12, 21130-014-24
  • Packager: Safeway, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated July 29, 2021

If you are a consumer or patient please visit this version.

  • 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

    Diphenhydramine HCl 50 mg

    SIGNATURE CARE NightTime Sleep Aid Berry Flavor

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-014
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-014-242 in 1 PACKAGE, COMBINATION06/30/2015
    1355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:21130-014-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2015
    3NDC:21130-014-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2015
    Labeler - Safeway, Inc. (009137209)