Label: SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 68210-4179-3
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • Drug Facts

  • Active Ingredient (in each tablet)

    Diphenhydramine HCI 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for relief of occasional sleeplessness

  • 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 emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

  • Ask a doctor or pharmacist before use if you are if you are

    • taking sedatives or tranquilizers

  • When using this product

    avoid alcoholic drinks

  • 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.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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 between 20–25°C (68–77°F)

  • Inactive ingredients

    FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol, titanium dioxide, water

  • Questions or comments?

    1-888-333-9792

  • Distributed by:

    Cabinet Health P.B.C.

  • Pouch

    Sleep Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4179
    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)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 903
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4179-330 in 1 POUCH; Type 0: Not a Combination Product11/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01011/21/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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