Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON (HEALTH MART)]

Z-SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [MCKESSON (HEALTH MART)]
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NDC 62011-0342-1
Set ID c051510e-96c5-4e72-bf1b-efd14020779e
Category HUMAN OTC DRUG LABEL
Packager McKesson (Health Mart)
Generic Name
Product Class
Product Number
Application Number PART338
  • Active ingredient (in each liquid-filled capsule)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

    • for relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
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  • 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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    avoid alcoholic beverages.

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away.

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  • Directions

    • do not take more than directed
    • take only one dose per day (24 hours)
    • adults and children 12 years and over: 2 capsules at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
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  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • protect from light
    • see end flap for expiration date and lot number
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid excessive heat above 40ºC (104ºF) and high humidity
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  • Inactive ingredients

    edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

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  • Questions or comments?

    1-800-426-9391

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  • Principal display panel

    Health Mart®

    NDC 62011-0342-1

    Compare to VICKS® ZzzQuil™
    NIGHTTIME SLEEP-AID LiquiCaps®
    active ingredient*

    Z-Sleep
    Diphenhydramine HCl 25 mg
    Nighttime Sleep-Aid

    Non-Habit Forming
    Not For Treating Cold or Flu

    Actual Size

    12 Liquid Gels

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark VICKS® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps®.

    50844   REV0716A65402

    Product of China
    Packaged and Quality Assured in the USA

    McKESSON
    Another Quality Product
    Distributed by McKesson
    One Post Street, San Francisco, CA 94104
    Money Back Guarantee
    healthmart.com

    44-654

    44-654

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  • INGREDIENTS AND APPEARANCE
    Z-SLEEP 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0342
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    Color PURPLE (clear) Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code 654
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62011-0342-1 1 in 1 CARTON 02/28/2015
    1 12 in 1 BLISTER PACK; 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 02/28/2015
    Labeler - McKesson (Health Mart) (177667227)
    Establishment
    Name Address ID/FEI Business Operations
    Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd 421293287 API MANUFACTURE(62011-0342)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(62011-0342)
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