Label: KROGER NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 23, 2022

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  • 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)
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