Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 69842-834-51, 69842-834-55
  • Packager: CVS Pharmacy, Inc.
  • 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 December 10, 2020

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  • Drug Facts

    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

    ■ 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

    ■ 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 37 mg

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    ■ protect from moisture

    ■ use by expiration date on package

  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark

    Simply Sleep®.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2018 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-34571

  • PRINCIPAL DISPLAY PANEL

    CVSHealth

    Compare to the active ingredient in Simply Sleep®*

    Nighttime

    Sleep-Aid

    DIPHENHYDRAMINE HCl, 25 mg

    Nighttime sleep-aid

    • Safe, non-habit forming

    • Fall asleep fast, wake up rested

    • Does not contain pain reliever

    500 MINI-CAPLETS

    CVS Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-834
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code CPC;2824
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-834-51365 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2018
    2NDC:69842-834-55500 in 1 BOTTLE; Type 0: Not a Combination Product01/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33807/23/2018
    Labeler - CVS Pharmacy, Inc. (062312574)
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