Label: EZ NITE SLEEP- diphenhydramine hcl liquid

  • NDC Code(s): 63868-016-06, 63868-016-13
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • 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 November 30, 2020

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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 the skin
    • in children under 12 years of age


    Ask a doctor before use if you have

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

    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
    • keep dosing cup with product
    • measure only with dosing cup provided. Do not use any other dosing device.
    • adults and children 12 years and over
      • one dose = 30 mL 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, trisodium citrate dihydrate

  • Questions or comments?

    Call 1-248-449-9300 Monday-friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the Active ingredient in ZZZQUIL®

    EZ Nite Sleep

    Nighttime Sleep Aid

    Diphenhydramine HCI 50 mg

    Non-Habit Forming

    Not for Treating Cold or Flu

    Alcohol 10%

    Berry Flavor

    fl oz (mL)

    failure to follow these warnings could result 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 Procter & Gamble Company.

    Distributed by C.D.M.A., Inc.©

    43157 W 9 Mile Rd

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Package Label

    Diphenhydramine HCI 50 mg

    QUALITY CHOICE EZ Nite Sleep

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-016
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-016-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201512/30/2022
    2NDC:63868-016-13355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201512/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/30/201512/30/2022
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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