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

  • NDC Code(s): 68210-4131-1
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each softgel)

    Diphenhydramine HCl 25 mg

  • Purpose

    nighttime sleep-aid

  • Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • WARNINGS

    Warnings

    Do not use

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

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema, or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease

    Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers or any other sleep aid

    When using this product

    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery

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

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

    Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

  • Directions

    • take only one dose per day (24 hours) - see Overdose warning
    adults & children 12 yrs & over One dose=TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
     children under 12 years Do not use

  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F) and high humidity
    • Protect from light
  • Inactive ingredients

    FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Nighttime sleep aid
    Diphenhydramine HCl 25 mg - Nighttime Sleep-Aid

    Helps reduce difficulty falling asleep

    Non-habit forming

    Not for treating pain, cold or flu

    12 Softgels

    Carton

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4131
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 602
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4131-11 in 1 CARTON04/27/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/27/2021
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
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