Label: EZ NITE SLEEP- diphenhydramine hydrochloride solution

  • NDC Code(s): 30142-549-30, 30142-549-40, 30142-549-50
  • Packager: Kroger Company
  • 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 May 13, 2019

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

    for children under 12 years of age
    with any other product containing diphenhydramine, even one used on skin
  • Ask a doctor before use if you have

    a breathing problem such as emphysema or chronic bronchitis
    glaucoma
    difficulty in urination due to enlargement of the 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 right away (1-800-222-1222).

  • Directions

    take only one dose per day (24 hours)
    only use the dose cup provided

    adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use

  • Other information

    each 30 mL contains: sodium 20 mg
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

  • Questions or comments?

    1-800-632-6900

  • Package/Label Principal Display Panel

    COMPARE TO the active ingredient of VICKS® ZZZQUIL® See back panel

    OUR PHARMACIST RECOMMENDED

    Nighttime Sleep-Aid

    EZ Nite Sleep

    Helps You Fall Asleep

    Diphenhydramine HCl 50mg per 30mL

    10% ALCOHOL

    Not for Treating Cold or Flu

    Non-Habit Forming

    Berry Flavor

    6 FL OZ (177mL)

    EZ Nite Sleep image
  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-549
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-549-30177 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2019
    2NDC:30142-549-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2019
    3NDC:30142-549-502 in 1 PACKAGE05/09/2019
    3355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33805/09/2019
    Labeler - Kroger Company (006999528)