UP AND UP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TARGET CORPORATION]

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UP AND UP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TARGET CORPORATION]
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NDC 11673-713-33, 11673-713-64
Set ID 20ca76fb-9039-4596-9143-70879d7ffdce
Category HUMAN OTC DRUG LABEL
Packager Target Corporation
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient (in each softgel)

    Diphenhydramine HCl 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 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 (1-800-222-1222).

  • Directions

    •
    adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    edible ink*, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Questions or comments?

    1-888-547-7400

  • Package/Label Principal Display Panel

    Compare to active ingredient in Unisom® SleepGels®

    nighttime sleep-aid

    diphenhydramine HCl, 50 mg

    non-habit forming

    60 SOFTGELS

    ACTUAL SIZE

    60 SOFTGELS

    5v6-uw-nighttime-sleep-aid-1.jpg
    5v6-uw-nighttime-sleep-aid-2.jpg
  • INGREDIENTS AND APPEARANCE
    UP AND UP NIGHTTIME SLEEP AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-713
    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 (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUE (clear to light blue) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 5V6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-713-331 in 1 CARTON06/05/2018
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11673-713-641 in 1 CARTON06/05/2018
    232 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33806/05/2018
    Labeler - Target Corporation (006961700)
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