Label: NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 68391-613-92
  • Packager: BJWC (Berkley & Jensen / BJ's)
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 19, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Purpose

    Nighttime sleep-aid

  • INDICATIONS & USAGE

    Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • WARNINGS

    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 (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • take only one dose (2 softgels) per day (24 hours)

    adults & children 12 yrs & over

    2 softgels at bedtime if needed or as directed by a doctor

    children under 12 yrs

    do not use

  • OTHER SAFETY INFORMATION

    Other information

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

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments? Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    613T-BJ- Nighttime sleep aid 192ct carton

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-613
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN (UNII: 6O92ICV9RU)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpurple (Purple, Translucent) Scoreno score
    ShapeCAPSULE (Oblong shaped) Size16mm
    FlavorImprint Code 121
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-613-9216 in 1 CARTON08/20/2025
    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 DrugM01008/20/2025
    Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(68391-613)
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