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

  • NDC Code(s): 53943-485-18
  • Packager: DISCOUNT DRUG MART, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 31, 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 (1-800-222-1222) 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

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

    MADE IN INDIA

    Distributed by: Discount Drug Mart
    211 Commerce Drive, Medina, Ohio 44256
    www.discount-drugmart.com

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE
    WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON
    FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO:
    DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

    T00194R0124

    Mfg. Lic. No.: TN00002123

    L0000784

    R0224

    Lot No.:
    Exp. Date:

  • 64's count

    NDC 53943-485-18

    discount

    drug

    mart

    food market

    AN EMPLOYEE OWNERSHIP COMPANY

    Nighttime Sleep-aid

    Diphenhydramine HCl Capsules, USP 50 mg

    • Fall asleep fast • Sleep soundly
    • Safe, non-habit forming

    One Softgel Per Dose

    †Compare to the active ingredient in Unisom® SleepGels®

    64 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:53943-485
    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:53943-485-181 in 1 CARTON03/20/2024
    164 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/20/2024
    Labeler - DISCOUNT DRUG MART, INC. (047741335)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(53943-485)