Home > Drugs A-Z > Unisom SleepGels Nighttime Sleep-Aid

Unisom SleepGels Nighttime Sleep-Aid (Chattem, Inc.)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BOTTLE, PLASTIC in 1 CARTON (41167-0061-3) > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC Label Information
CAPSULE, LIQUID FILLED 2 BLISTER PACK in 1 CARTON (41167-0061-1) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information
CAPSULE, LIQUID FILLED 1 BLISTER PACK in 1 CARTON (41167-0061-0) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information
CAPSULE, LIQUID FILLED 1 BOTTLE, PLASTIC in 1 CARTON (41167-0061-6) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC Label Information

Complete Unisom SleepGels Nighttime Sleep-Aid Information

  • 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 (245-189)






  • PRINCIPAL DISPLAY PANEL

    Unisom
    #1 PHARMACIST RECOMMENDED INGREDIENT*
    SLEEPGELS
    Diphenhydramine HCI SoftGels, 50 mg
    NIGHTTIME SLEEP-AID
    32 SOFTGELS LIQUID FILLED
    JUST ONE SOFTGEL PER DOSE

    PRINCIPAL DISPLAY PANEL
Unisom
#1 PHARMACIST RECOMMENDED INGREDIENT*
SLEEPGELS
Diphenhydramine HCI SoftGels, 50 mg
NIGHTTIME SLEEP-AID
32 SOFTGELS LIQUID FILLED
JUST ONE SOFTGEL PER DOSE


  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPGELS NIGHTTIME SLEEP-AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0061
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code UNISOM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0061-0 1 in 1 CARTON 01/01/2007
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:41167-0061-1 2 in 1 CARTON 01/01/2007
    2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:41167-0061-2 1 in 1 CARTON 09/15/2017
    3 100 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:41167-0061-3 1 in 1 CARTON 01/01/2007
    4 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5 NDC:41167-0061-6 1 in 1 CARTON 01/01/2007
    5 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6 NDC:41167-0061-5 1 in 1 CARTON 01/01/2007
    6 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 01/01/2007
    Labeler - Chattem, Inc. (003336013)