Label: SLEEP AID- diphenhydramine hcl capsule

  • NDC Code(s): 55319-564-32, 55319-564-64
  • Packager: Family Dollar (FAMILY WELLNESS)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 26, 2024

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

View All Sections
  • Active ingredient (in each softgel)

    Diphenhydramine HCL 50 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    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

    taking sedatives or tranquilizers.

    When using this product

    avoid alcoholic drinks.

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (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 between 15-30°C (59°-86°F)
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENT IN UNISOM® SLEEPGELS®†

    SLEEP-AID

    Diphenhydramine HCL 50 mg

    NIGHTTIME SLEEP-AID

    • Fall asleep fast
    • Sleep soundly
    • Wake up refreshed

    Non Habit-Forming

    SOFTGELS

    One Softgel Per Dose

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    †This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

    DISTRIBUTED BY

    MIDWOOD BRANDS LLC

    500 VOLVO PKWY,

    CHESAPEAKE, VA 23320

  • Package Label

    Diphenhydramine HCl 50 mg

    FAMILY WELLNESS Nighttime Sleep-Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-564
    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)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code PC5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-564-321 in 1 BOX07/01/2023
    132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:55319-564-641 in 1 BOX07/01/2023
    264 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01007/01/2023
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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!