Label: SLEEP- diphenhydramine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 14, 2023

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  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • 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

    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    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 right away.

  • Directions

    • do not take more than directed
    • adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • each tablet contains: calcium 60 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • protect from moisture
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    NIGHTTIME SLEEP AID

    WAKE RESTED
    AND REFRESHED

    COMPARE TO
    ORIGINAL FORMULA
    SOMINEX® ACTIVE
    INGREDIENT*

    CVP®
    HEALTH

    SLEEP TABLETS

    DIPHENHYDRAMINE HCl 25 mg
    NIGHTTIME SLEEP AID

    Actual Size

    16 TABLETS

    WAKE RESTED
    AND REFRESHED

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
    OPENED OR IF BLISTER UNIT IS TORN, BROKEN
    OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Medtech Products
    Inc., owner of the registered trademark Original Formula Sominex®.
    50844         REV1019S18921

    Distributed by Consumer Value Products, Inc.
    P.O. Box 6115, Temple, Texas 76502
    CVPproducts.com

    CVP 44-189

    CVP 44-189

  • INGREDIENTS AND APPEARANCE
    SLEEP 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-189
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorblue (light) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;189
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-189-212 in 1 CARTON04/10/1990
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/10/1990
    Labeler - Salado Sales, Inc. (009830555)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(57243-189)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(57243-189) , pack(57243-189)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(57243-189)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(57243-189)
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