Label: SLEEPEZE GELCAPS- diphenhydramine hydrochloride capsule, gelatin coated

  • 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 capsule)

    Diphenhydramine Hydrochloride 50 mg

  • Purpose

    Nighttime sleep aid

  • Uses

    ● relieves occasional sleeplessness

  • 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 capsule 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

    FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, sorbitan, sorbitol, water

  • Questions?

    1-800-443-4908

    .

  • PRINCIPAL DISPLAY PANEL

    Sleep•eze® MD
    extra strength
    gelcaps
    DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 50 mg
    20 soft gel capsules

    DIN 02238644

    Sleep•eze® MD extra strength Gel Caps DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 50 mg 20 soft gel capsules DIN 02238644

  • INGREDIENTS AND APPEARANCE
    SLEEPEZE GELCAPS 
    diphenhydramine hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-927
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize1mm
    FlavorImprint Code P50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-927-201 in 1 CARTON05/23/2012
    110 in 1 BOTTLE; 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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