Label: NIGHTTIME SLEEP AID- diphenhydramine hcl tablet, film coated

  • NDC Code(s): 62011-0343-1
  • Packager: Strategic Sourcing Services, LLC (Health Mart)
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 5, 2023

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  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    for relief of occasional sleeplessness

  • Warnings

    Do not use

    • in 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
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • use caution when driving a motor vehicle or operating machinery 
    • drowsiness will occur
    • 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.

  • Directions

    • do not take more than directed
    • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each caplet contains: calcium 30 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • protect from moisture
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

  • Questions or comments?

    Call 1-800-426-9391

  • Principal display panel

    Health Mart®

    NDC 62011-0343-1

    *Compare to Simply Sleep® active ingredient

    Nighttime Sleep Aid
    Diphenhydramine HCl 25 mg
    Nighttime Sleep-Aid

    Helps You Fall Asleep

    Does NOT Contain Pain Reliever • Non-Habit Forming

    Actual Size

    24 Caplets

    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 McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.
    50844            REV0516A36708

    McKESSON

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

    44-367

    44-367

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0343
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0343-12 in 1 CARTON06/10/200009/19/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01006/10/200009/19/2024
    Labeler - Strategic Sourcing Services, LLC (Health Mart) (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(62011-0343)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(62011-0343)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(62011-0343)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(62011-0343) , pack(62011-0343)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(62011-0343)
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