Label: SLEEPAID SOFTGELS- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 72090-023-02
  • Packager: PIONEER LIFE SCIENCES, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2024

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  • Active Ingredient (In Each Softgel)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    for relief of occasional sleeplessness

  • 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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • STOP USE

    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.

  • 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 right away. (1-800-222-1222)

  • 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 15-30°C (59-86°F). Avoid high humidity. Protect from light.

  • Inactive Ingredients:

    Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF.

  • Questions Or Comments?

    Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

    Distributed by: Gencare Consumer Products, LLC
    40E Cotters Ln, Suite A, East Brunswick, NJ 08816

  • NDC 72090-023-02 (96 Sofgels t in HDPE Bottle)

    PL0166-SleepAid SoftGels Diphenhydramine HCL 50mg-96cts-02.05.24 Signed_page-0001

  • INGREDIENTS AND APPEARANCE
    SLEEPAID SOFTGELS 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-023
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code cp71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-023-0296 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01004/25/2024
    Labeler - PIONEER LIFE SCIENCES, LLC (014092742)
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