Label: NYTOL- diphenhydramine hcl capsule, gelatin coated

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

Drug Label Information

Updated January 19, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

  • Purpose

    Diphenhydramine Hydrochloride 50 mg             Nighttime sleep aid

      

  • Uses/ Indications

    ● helps to reduce difficulty falling asleep

    ● 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 breast-feeding

    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 between 15 & 30 °C

  • Inactive ingredients

    edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan

  • Questions?

    1-800-465-8811 www.nytol.ca

  • PRINCIPAL DISPLAY PANEL

    Extra Strength Ultra-fort

    Nytol®/MD

    QUICKGELS®

    GÉLULES-RAPIDESMC

    Extra Strength Ultra-fort

    50 mg Diphenhydramine Hydrochloride Capsules USP

    Capsules de chlorhydrate de diphenhydramine 50 mg USP

    16 soft gels

    gélules molles

    DIN 02237169

    PRINCIPAL DISPLAY PANEL Extra Strength Ultra-fort Nytol®/MD QUICKGELS® GÉLULES-RAPIDESMC Extra Strength Ultra-fort 50 mg Diphenhydramine Hydrochloride Capsules USP Capsules de chlorhydrate de diphenhydramine 50 mg USP 16 soft gels gélules molles DIN 02237169

  • INGREDIENTS AND APPEARANCE
    NYTOL 
    diphenhydramine hcl capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-928
    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 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize1mm
    FlavorImprint Code N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-928-162 in 1 CARTON06/01/2012
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only06/01/2012
    Labeler - Medtech Products Inc. (122715688)
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