SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) CAPSULE [SAM'S WEST, INC]

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SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) CAPSULE [SAM'S WEST, INC]
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NDC 68196-835-92
Set ID 07abc89d-247d-4cd2-9e7e-3965e67c4891
Category HUMAN OTC DRUG LABEL
Packager Sam's West, Inc
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • For relief of occasional sleeplessness.


  • 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • avoid alcoholic drinks


    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222).

  • Directions

    • adults and children 12 years of age and older: 1 softgel  (50 mg) at bedtime if needed, or as directed by a doctor


  • Other information

    • store between 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol sorbitan*

    *contains one or more of these ingredients 

  • Questions or comments?

    Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Unisom® SleepGels® active ingredient**

    maximum strength

    Sleep-Aid

    diphenhydramine HCl 50 mg

    nighttime sleep-aid

    safe, non habit-forming

    • Fall asleep fast
    • Sleep soundly/wake up refreshed

    Softgels

    **This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY

    SAM'S WEST, INC.

    BENTONVILLE, AR 72716

  • Product Label

    Diphenhydramine HCl 50 mg

    MEMBER'S MARK Maximum Strength Sleep-Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID  NIGHTTIME
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-835
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code P50;A99;D50;AP018
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-835-922 in 1 PACKAGE03/31/201912/27/2024
    196 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33803/31/201912/27/2024
    Labeler - Sam's West, Inc (051957769)
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