Label: UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride tablet, chewable

  • NDC Code(s): 63868-393-24
  • Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each caplet)

    Diphenhydramine HCI 25 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 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 at 1-800-222-1222.

  • Directions

    •
    adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor
    •
    place 2 tablets on tongue; tablets dissolve with or without water
    •
    allow tablets to dissolve in mouth or chew before swallowing

    Other Information

    •
    store at room temperature
  • Inactive ingredients

    citric acid, crospovidone, dextrose. FD&C RED # 40, flavor, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    *Compare to the Active Ingredient in Unisom® SleepMelts™

    Nighttime Sleep Aid
    Diphenhydramine HCI Tablets, 25 mg
    24 Quick-Dissolving Tablets

    Non-Habit Forming

    Cherry Flavor

    100% SATISFACTION GUARANTEED

    Distributed By C.D.M.A., Inc.©

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

    DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.

    *This product is not manufactured or distributed by Chattern Inc., owner of the registered trademark Unisom® SleepMelts™

    UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride tablet, chewable
  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID 
    diphenhydramine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-393
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize13mm
    FlavorCHERRYImprint Code U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-393-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product01/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01001/07/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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