Label: SLEEPEZE- diphenhydramine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

  • Purpose

    Diphenhydramine Hydrochloride 25 mg………………Nighttime sleep aid

  • Uses

    ● relieves occasional sleeplessness ● helps to reduce difficulty falling asleep

  • Warnings

    Do not use

    ●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age

    Ask a doctor or pharmacist before use if you

    ●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding

    When using this product

    avoid drinking alcohol.

    Stop use and ask a doctor if

    sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness.

    Keep out of reach of children.

    In case of overdose, call a poison control centre or get medical help right away.

  • Directions

    ●Adults and children 12 years and over: ▪take 1 or 2 tablets at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, reduce dose to 1 tablet

    ▪do not take more than directed

  • Other information

    ▪ Store at 20° to 25°C

  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin

  • Questions?

    1-800-443-4908

  • PRINCIPAL DISPLAY PANEL

    Sleep.eze

    Regular Strength
    Caplets
    Diphenhydramine Hydrochloride Tablets 25 mg

    20 coated caplets

    PRINCIPAL DISPLAY PANEL Sleep.eze Regular Strength Caplets Diphenhydramine Hydrochloride Tablets 25 mg 20 coated caplets

  • INGREDIENTS AND APPEARANCE
    SLEEPEZE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-920
    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
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code S;Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-920-202 in 1 CARTON05/24/2012
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only05/24/2012
    Labeler - Medtech Products Inc. (122715688)
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