UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]

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UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]
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NDC 41167-0067-0, 41167-0067-2
Set ID a9a44c2f-65eb-4a5a-9e72-43652dce57f7
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 mini-capsule)

    Diphenhydramine HCI 25 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: 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor
  • Inactive ingredients

    blue 1, citric acid, gelatin, lactose, polysorbate 80, potassium sorbate, pregelatinized corn starch, red 3, titanium dioxide (309-121)

  • PRINCIPAL DISPLAY PANEL

    Unisom
    #1 Pharmacist Recommended Ingredient*
    SleepMinis
    Diphenhydramine HCI
    Mini-Capsules, 25 mg
    NIGHTTIME SLEEP-AID
    20 Mini-Capsules

    Unisom #1 Pharmacist Recommended Ingredient* SleepMinis Diphenhydramine HCI Mini-Capsules, 25 mg NIGHTTIME SLEEP-AID 20 Mini-Capsules

  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0067
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (with a blue band) Scoreno score
    ShapeOVALSize14mm
    FlavorImprint Code SleepMinis
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0067-21 in 1 CARTON04/01/2015
    120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:41167-0067-01 in 1 CARTON04/01/2015
    260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33804/01/2015
    Labeler - Chattem, Inc. (003336013)
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