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

Drug Label Information

Updated September 23, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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

    Ask a doctor before use if you have

    • breathing problem such as asthma emphysema or chronic bronchitis
    • glaucoma
    • 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.

  • Directions

    • take only one dose per day (24 hours)
    • 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 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, sodium citrate dihydrate

  • Questions or comments?

  • Principal Display Panel

    COMPARE TO ZZZQUIL® active ingredient*

    NIGHTTIME SLEEP AID

    NIGHTTIME SLEEP-AID

    DIPHENHYDRAMINE HCI 50 mg

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

    BERRY FLAVOR

    fl oz (mL)

    Failure to follow these warnings could results 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 Proctor & Gamble Company.

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC

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

  • Package Label

    Diphenhydramine HCl 50 mg

    SIGNATURE SELECT 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 STEARATE 40 (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:21130-014-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2015
    2NDC:21130-014-242 in 1 PACKAGE, COMBINATION06/30/2015
    2355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:21130-014-06177 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 DrugM01206/30/2015
    Labeler - Safeway, Inc. (009137209)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!