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

Drug Label Information

Updated November 5, 2024

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  • 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?

    1-800-632-6900

  • Package/Label Principal Display Panel

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

    Kroger®

    Nighttime Sleep-Aid

    EZ Nite Sleep

    Diphenhydramine HCl 50mg per 30mL

    Helps You Fall Asleep

    OUR PHARMACIST RECOMMENDED

    Not for Treating Cold or Flu

    Non-Habit Forming

    ALCOHOL 10%

    Berry Flavor

    12 FL OZ (354 mL)

    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, UNSPECIFIED FORM (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 Product05/09/201906/30/2024
    2NDC:30142-549-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/201904/30/2026
    3NDC:30142-549-502 in 1 PACKAGE05/09/201905/31/2024
    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 DrugM01005/09/201904/30/2026
    Labeler - Kroger Company (006999528)
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