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

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  • UNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]

UNISOM SLEEPGELS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]
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NDC 41167-0061-0, 41167-0061-1, 41167-0061-2, 41167-0061-3, 41167-0061-5, 41167-0061-6
Set ID 17383d22-91cc-4d9e-a0b8-3f7d9a18af83
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 softgel)

    Diphenhydramine HCI 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
  • Inactive ingredients

    blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide, water (309-153)

  • PRINCIPAL DISPLAY PANEL

    Unisom
    SleepGels
    Diphenhydramine HCI
    SoftGels, 50 mg
    #1 Pharmacist Recommended Brand*
    NIGHTTIME SLEEP-AID
    32 SoftGels
    One SoftGel per dose

    Unisom SleepGels Diphenhydramine HCI SoftGels, 50 mg #1 Pharmacist Recommended Brand* NIGHTTIME SLEEP-AID 32 SoftGels One SoftGel per dose

  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPGELS NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0061
    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)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code UNISOM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0061-01 in 1 CARTON01/01/2007
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0061-12 in 1 CARTON01/01/2007
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-0061-21 in 1 CARTON09/15/2017
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-0061-31 in 1 CARTON01/01/2007
    432 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:41167-0061-61 in 1 CARTON01/01/2007
    560 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:41167-0061-51 in 1 CARTON01/01/2007
    640 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33801/01/2007
    Labeler - Chattem, Inc. (003336013)
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