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

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

Drug Label Information

Updated October 10, 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.

    READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

    Made in USA using domestic and imported materials.

    †This product is not manufactured or distributed by the

    owners of Unisom ® SleepGels ®.

    Lot No.:

    Exp. Date:

    Distributed By
    AmerisourceBergen
    1 West First Ave
    Conshohocken, PA 19428
    Questions or Concerns?
    www.mygnp.com

    L0000442

    Rev # 04/21

  • 60's Count Carton

    GOOD

    NEIGHBOR

    PHARMACY®

    Compare to the active ingredient in Unisom® SleepGels®†

    NDC 46122-695-72

    Maximum Strength

    Nighttime Sleep-aid

    Diphenhydramine HCl Capsules, 50 mg

    Fall Asleep Fast
    • sleep soundly • safe, non-habit forming

    One Softgel Per Dose

    60 softgels** I (**Liquid-filled capsules)

    60's Carton

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-695
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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:46122-695-721 in 1 CARTON07/15/2021
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01007/15/2021
    Labeler - AMERISOURCE BERGEN (007914906)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(46122-695)
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