Label: UNISOM SLEEPGELS NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled

  • NDC Code(s): 41167-0061-0, 41167-0061-1, 41167-0061-2, 41167-0061-3, view more
    41167-0061-5, 41167-0061-6
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 1, 2007

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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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