Label: SLEEP AID NIGHTTIME- diphenhydramine hcl capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 8, 2022

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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  (1-800-222-1222) right away

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

    FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitan, sorbitol, white ink

  • Questions or comments?

    Call 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 MARK Sleep Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID  NIGHTTIME
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-916
    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)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code PC5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-916-922 in 1 PACKAGE04/01/202004/01/2025
    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 finalpart33804/01/202004/01/2025
    Labeler - Sam's West, Inc (051957769)
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