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

  • 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 13, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    • 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 persist continuously for more than 2 weeks. 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: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
  • Other information

    • Store at 15°-30°C (59°-86°F)
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

  • Questions or comments?

    Call toll free: 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL - Bottle Label

    TopCare Nighttime Sleep Aid

    Diphenhydramine HCl 50 mg 96SOFTGELS

    NDC 36800-413-96

    *Compare to the active ingredient in Unisom® SleepGels®

    Bottle Label Front

    Bottle Label Back

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-413
    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)  
    Product Characteristics
    Colorblue (clear) Scoreno score
    Shapecapsule (oval) Size13mm
    FlavorImprint Code PC5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-413-9696 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33807/19/2016
    Labeler - Topco Associates LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(36800-413) , analysis(36800-413)
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