KROGER NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [KROGER COMPANY]

KROGER NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [KROGER COMPANY]
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NDC 30142-116-01
Set ID 8b600379-bbec-417d-8924-973eaba3d7d3
Category HUMAN OTC DRUG LABEL
Packager KROGER COMPANY
Generic Name
Product Class
Product Number
Application Number PART338
  • Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    for the relief of occasional sleeplessness

  • WARNINGS

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking
    sedatives or tranquilizers

  • When using this product

    ■ avoid alcoholic drinks ■ drowsiness will occur
    ■ do not drive a motor vehicle or operate machinery

  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Overdose warning

    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 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 23.52 mg
    ■ store between 20-25°C (68-77°F). Avoid high
    humidity. Protect from light.

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium,
    dicalcium phosphate, FD&C Blue #1, FD&C Blue #2,
    lecithin, magnesium stearate, microcrystalline cellulose,
    polyethylene glycol, polyvinyl alcohol, talc, titanium
    dioxide

  • QUESTIONS

    Questions or comments? 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*

    Kroger

    NDC 30142-116-01

    Nighttime Sleep-Aid

    Diphenhydramine HCl, 25mg

    Does NOT contain Pain Reliever

    For a Restful

    Night's Sleep

    SAFE, NON-HABIT FORMING

    100

    MINI-CAPLETS

    actual size

    *Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.

    image description

  • INGREDIENTS AND APPEARANCE
    KROGER NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-116
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code S5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-116-011 in 1 CARTON04/16/2019
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33804/16/2019
    Labeler - KROGER COMPANY (006999528)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(30142-116)

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