UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]

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  • UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]

UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]
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NDC 41167-0014-0, 41167-0014-1
Set ID 9105f4f1-7f94-408d-a025-83afb68dc9f0
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART338
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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.

  • 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
  • Inactive ingredients

    citric acid, ethylcellulose, flavor, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, PVP, red 7, starch, sucralose, sucrose (309-154)

    Dist. by: CHATTEM, Inc.
    P.O. Box 2219, Chattanooga, TN 37409 USA
    © 2011 Chattem Inc. www.chattem.com 

  • PRINCIPAL DISPLAY PANEL

    Unisom®
    SleepMeltsTM 
    Diphenhydramine HCI tablets, 25 mg
    NIGHTTIME SLEEP-AID
    24 Tablets

    Unisom® SleepMeltsTM Diphenhydramine HCI tablets, 25 mg NIGHTTIME SLEEP-AID 24 Tablets

  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID 
    diphenhydramine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0014
    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)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize13mm
    FlavorCHERRYImprint Code U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0014-03 in 1 CARTON01/01/2008
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0014-14 in 1 CARTON01/01/2008
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33801/01/2008
    Labeler - Chattem, Inc. (003336013)
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