EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [THE KROGER CO.]

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EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [THE KROGER CO.]
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NDC 30142-375-06, 30142-375-12, 30142-375-24
Set ID 8470b8b8-3462-49fd-aa40-51c666f38fe5
Category HUMAN OTC DRUG LABEL
Packager The Kroger Co.
Generic Name
Product Class
Product Number
Application Number PART341
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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

    • 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 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 (1-800-222-1222) 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 24 mg
    • store between  20-25ºC (68-77ºF). Do not refrigerate.
    • protect from light
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium anhydrous, sodium benzoate, trisodium citrate dihydrate

  • Questions or comments?

    1-800-632-6900

  • Principal Display Panel

    COMPARE TO the active ingredient of VICKS® ZZZQUIL®

    *See back panel

    EZ Nite Sleep

    Diphenhydramine HCI 50 mg

    Nighttime Sleep-Aid

    Non-Habit Forming

    Alcohol Free

    • Not for treating cold or flu

    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.

    *Vicks® ZZZQUIL® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202.The Procter & Gamble Company is not Affiliated with the Kroger Co. or this product.

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

    www.kroger.com

  • Package Label

    Diphenhydramine HCI 50 mg

    KROGER EZ Nite Sleep

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-375
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-375-242 in 1 PACKAGE03/31/2015
    1355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:30142-375-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2015
    3NDC:30142-375-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/31/2015
    Labeler - The Kroger Co. (006999528)
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