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

  • NDC Code(s): 63941-683-17
  • Packager: VALU MERCHANDISERS COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 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 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
  • 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 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 oC to 25 oC (68 oF to 77 oF)
    • avoid high humidity and excessive heat above 40 oC (104 oF).
    • protect from light
  • Inactive ingredients

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

  • Questions or comments?

    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 manufacturerd or distributed by the owners of Unisom® SleepGels®.

    PROUDLY DISTRIBUTED BY: ASSOCIATED WHOLESALE GROCERS, INC.

    KANSAS CITY, KANSAS 66106

    For product information please visit: bestchoicebrand.com/66729

    R0523

    L0000720

  • 60's carton

    Best

    Choice®

    *Compare to the

    active ingredient in

    Unisom®

    SleepGels®

    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**

    **LIQUID-FILLED CAPSULES

    image001

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-683
    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
    SORBITAN (UNII: 6O92ICV9RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code P50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-683-171 in 1 CARTON10/12/2023
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01010/12/2023
    Labeler - VALU MERCHANDISERS COMPANY (868703513)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc002193829manufacture(63941-683)
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