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

  • NDC Code(s): 68210-4089-1
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    CABINET

    NIGHTTIME

    SLEEP-AID

    DIPHENHYDRAMINE HCl 25 mg

    48 SOFTGELS

    image description

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4089
    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:68210-4089-14 in 1 CARTON07/02/2020
    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 DrugM01007/02/2020
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!