Label: EZ NITE SLEEP- diphenhyramine hydrochloride capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 17, 2024

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  • Drug Facts

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25 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.

    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 aretaking sedatives or tranquilizers

    When using this product
    ■ avoid alcoholic beverages

    Stop use and ask a doctor ifsleeplessness 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)


    adults & children 12 yrs & over
    		2 softgels at bedtime if needed or as directed by a doctor
    children under 12 yrsdo not use

  • Other information

    ■ store at 20-25° C (68-77°F)
    ■ avoid excessive heat above 40°C (104°F)
    ■ protect from light

  • Inactive ingredients

    FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

  • QUESTIONS

    Questions or comments? Call 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    diphenhydramine-sg-24s-ifc

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhyramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SHELLAC (UNII: 46N107B71O)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colorpurple (Purple,translucent) Scoreno score
    ShapeCAPSULE (oblong shaped) Size16mm
    FlavorImprint Code 121
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-613-242 in 1 CARTON04/15/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/15/2024
    Labeler - KROGER COMPANY (006999528)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(41226-613)
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