Label: UNISOM SLEEPMELTS- diphenhydramine hydrochloride tablet, chewable

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/11

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    (in each caplet)

    Diphenhydramine HCI 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

    • for relief of occasional sleeplessness
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  • 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.

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  • Directions

    • adults and children 12 years of age and over: 2 sleep melts (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
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  • Inactive ingredients

    citric acid, ethylcellulose, flavor, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, PVP, red 7, starch, sucralose, sucrose (245-236)

    Dist. by: CHATTEM, Inc.
    P.O. Box 2219, Chattanooga, TN 37409 USA
    © 2008 Chattem Inc. www.chattem.com 

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  • PRINCIPAL DISPLAY PANEL

    Unisom®
    SleepMeltsTM 
    Diphenhydramine HCI
    NIGHTTIME SLEEP-AID

    25 mg per tablet

    PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPMELTS 
    diphenhydramine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-0014
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID  
    ETHYLCELLULOSES  
    HYDROXYPROPYL CELLULOSE  
    MANNITOL  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    D&C RED NO. 7  
    STARCH, CORN  
    SUCRALOSE  
    SUCROSE  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 13mm
    Flavor CHERRY Imprint Code U
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0014-0 3 in 1 CARTON
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 01/01/2008
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Eurand, Inc. 097916506 MANUFACTURE
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