ZZZSLEEP (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]

ZZZSLEEP (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]
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NDC 76168-066-02
Set ID 3eb097a8-bdec-484e-9fad-5b141ef0a5af
Category HUMAN OTC DRUG LABEL
Packager Velocity Pharma
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient

    (in each tablet)

    Diphenhydramine HCl 25mg

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  • Purpose

    Sleep Aid

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  • Uses

    • For the relief of occasional sleeplessness
    • Reduces time to fall asleep if have difficulty falling asleep
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  • Warnings

    Do not use

    • If children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
    • Do not use with generic NyQuil®

    Ask a doctor before use if you have:

    • A breathing problem such as asthma, emphysema, or Chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease
    • You are taking a diuretic

      Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :

    • Avoid alcoholic beverages and other drugs that cause drowsiness
    • Drowsiness will occur
    • Be careful when driving a motor vehicle or operating machinery

      Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.

      Insomnia may be a symptom of serious underlying medical illness.

      If pregnant or breast-feeding, ask a health professional before use.

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  • Keep out of reach of children.

    Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Take only one dose per day (24 hours)- see Overdose warning.

    Adults and Children 12 years and over

    • One Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor
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  • Other Information

    • Store at 20-25°C (68-77°F)
    • Avoid excessive heat above 40°C(104°F) and high humidity
    • Protect from light
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  • Inactive Ingredients

    FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

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  • Questions?

    Call 1-855-314-1850

    TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. 

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    3699cb9c-figure-01

    NDC: 76168-066-02 –12 LIQUID GELS

    Not for treating cold or flu – see warnings

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  • INGREDIENTS AND APPEARANCE
    ZZZSLEEP 
    diphenhydramine capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-066
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color PURPLE Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code 602
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76168-066-02 12 in 1 BOTTLE
    1 1 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/15/2013
    Labeler - Velocity Pharma (962198409)
    Registrant - Velocity Pharma (962198409)
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