Label: SLEEPEZE- diphenhydramine hydrochloride tablet

  • NDC Code(s): 63029-921-10, 63029-921-20
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

  • Purpose

    Diphenhydramine Hydrochloride 50 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 tablet at bedtime if needed, or as directed by a doctor ▪ if you feel drowsy in the morning, consult a doctor or pharmacist as you may require a lower dosage (25 mg) ▪ do not take more than directed

  • Other information

    ▪ Store at 20° to 25°C

  • Inactive ingredients

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

    SECURITY FEATURE: Safety sealed in individual pouches. Do not use if pouch is not safely sealed.

    Important: Keep carton for future reference.

  • PRINCIPAL DISPLAY PANEL

    Sleep.eze
    Extra strength
    Caplets
    10 coated capsules

    PRINCIPAL DISPLAY PANEL Sleep.eze Extra strength Caplets 10 coated capsules

  • INGREDIENTS AND APPEARANCE
    SLEEPEZE 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-921
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 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)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code S;Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-921-101 in 1 CARTON05/23/2012
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63029-921-202 in 1 CARTON05/23/2012
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only05/23/2012
    Labeler - Medtech Products Inc. (122715688)
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