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

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

Drug Label Information

Updated April 22, 2024

If you are a consumer or patient please visit this version.

  • 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 continuosly 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 Center 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, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

  • 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

    Distributed By

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

    ABC#: 10287782 Rev: 04/24

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

    Mfg. Lic. No.: TN00002123

    Made in India

    T00186R0324

    L0000797

    R0324

    Lot No.:
    Exp. Date:

  • 60's count

    Compare to the active ingredient in Unisom® SleepGels®

    NDC 46122-775-64

    GOOD

    NEIGHBOR

    PHARMACY

    Maximum Strength

    Nighttime Sleep-Aid

    Diphenhydramine HCl Capsules, USP 50 mg

    Fall Asleep Fast

    • sleep soundly • safe, non-habit forming

    One Softgel Per Dose

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

    image001

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-775
    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
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SORBITAN (UNII: 6O92ICV9RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code B50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-775-641 in 1 CARTON04/11/2024
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/11/2024
    Labeler - AMERISOURCE BERGEN (007914906)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(46122-775)