Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • NDC Code(s): 51316-347-05, 51316-347-06
  • Packager: CVS Pharmacy, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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  • Drug Facts

    Active ingredient (in each mini-capsule)
    Diphenhydramine HCl 25 mg

  • PURPOSE

    Purpose
    Nighttime sleep-aid

  • Use

    for relief of occasional sleeplessness

  • WARNINGS

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged 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 a Poison Control Center (1-800-222-1222) right away.

  • Directions

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

    • store in a dry place at 15° – 30°C (59° – 86°F)
    • use by expiration date on package
    • protect from moisture
  • INACTIVE INGREDIENT

    anhydrous citric acid, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose monohydrate, magnesium stearate, polysorbate 80, potassium sorbate, sodium lauryl sulfate, titanium dioxide.

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2023 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.
    V-34571

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

    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.

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Unisom® SleepMinis®*

    Nighttime
    DIPHENHYDRAMINE HCl, 25 mg
    Nighttime sleep-aid
    Non-habit forming

    120 MINI-CAPSULES

    CVS Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-347
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 5347
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-347-051 in 1 CARTON02/02/2023
    1120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51316-347-06365 in 1 BOTTLE; Type 0: Not a Combination Product04/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01002/02/2023
    Labeler - CVS Pharmacy, Inc (062312574)
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