Label: NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 83059-0028-8
  • Packager: Shield Pharmaceuticals Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for relief of occasional sleeplessness

  • Warnings

  • DO NOT USE

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin

  • ASK DOCTOR

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an
    • enlarged prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers

  • WHEN USING

    When using this product avoid alcoholic drinks

  • STOP USE

    Stop use and ask a doctor if
    sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

  • Other information

    • store at controlled room temperature 20-25ºC (68-77ºF)
    • protect from light, heat and moisture

  • Inactive ingredients

    FD&C Blue #1, gelatin, glycerine, polyethylene glycol 400, propylene glycol, sorbitan

  • Questions or comments?

    1-800-373-6981

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Shield Pharmaceuticals Corp.
    Hauppauge, NY 11788

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Unisom® SleepGels

    Sleep-Aid

    Diphenhydramine HCI Softgels, 50 mg


    Carton

    Nighttime Sleep Aid Carton

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0028
    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 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code SD28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83059-0028-81 in 1 CARTON04/08/2024
    18 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/08/2024
    Labeler - Shield Pharmaceuticals Corp (118724924)
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