Label: DIPHENHYDRAMINE HCL capsule

  • NDC Code(s): 69842-537-11, 69842-537-51
  • 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 April 2, 2020

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  • Drug Facts

    Active Ingredient (in each mini-capsule)

    Diphenhydramine HCl 25mg

  • PURPOSE

    Purpose

    Nighttime sleep-aid

  • Uses

    for relief of occasional sleeplessness

  • 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 brochitis
    • glaucoma
    • 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 Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 12 years and over: take 2 mini-capsules (50mg) at bedtime if nedded, or as directed by a doctor
  • Other Information

    • Store at 25ºC(77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
    • protect from moisture
  • INACTIVE INGREDIENT

    citric acid, edible ink, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, lactose, polysorbate 80, potassium sorbate, starch, titanium dioxide

  • Question or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

    BAND AROUND CAPSULE IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Chattem, Inc., owner of the trademarks Unisom® and SleepMinis™.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL

    CVSHealth

    Compare to the active ingredient in Unisom® SleepMinis™*

    Nighttime Sleep-Aid

    Diphenhydramine HCl, 25mg

    Nighttime sleep-aid

    Non-habit forming

    60 Mini-Capsules

    5347-60ct-label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-537
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 5347
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-537-111 in 1 CARTON06/22/2018
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69842-537-51365 in 1 BOTTLE; Type 0: Not a Combination Product06/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33806/22/2018
    Labeler - CVS Pharmacy, Inc. (062312574)
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