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

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

Drug Label Information

Updated December 26, 2023

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  • Active ingredient (in each capsule)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    ■ for 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

    ■ glaucoma
    ■ a breathing problem such as emphysema or chronic bronchitis
    ■ 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
    ■ be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks, consult your doctor. 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 Centre right away.

  • Directions

    ■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
    ■ swallow whole; do not crush, chew, or dissolve

  • Other information

    ■ store at 20°C to 25°C (68°F to 77°F)
    ■ avoid high humidity and excessive heat above 40°C (104°F).
    ■ protect from light

  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

    †This product is not manufactured or distributed by the owners of Unisom ®SleepGels ®.

    Made in USA using domestic and imported materials.

    Manufactured for:
    Bionpharma Inc.
    Princeton, NJ 08540


    R0223 Lot No.: Exp. Date

    L0000704

  • 160's count Label

    †Compare to the active ingredient in Unisom ®SleepGels ®

    NDC 69452-322-79

    a+health

    maximum strength

    nighttime
    sleep-aid

    diphenhydramine HCl capsules, 50 mg

    • fall asleep fast
    • sleep soundly
    • safe, non-habit forming

    160 softgels**

    **liquid-filled capsules

    one softgel per dose

    front

    back

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-322
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code P50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-322-79160 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/27/2021
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-322)
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