Label: SLEEP AID capsule, liquid filled

  • NDC Code(s): 21130-052-32, 21130-052-96
  • Packager: Better Living Brands LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient(s)

    Diphenhydramine HCl 50mg

  • Purpose

    Nighttime sleep aid

  • Use(s)

    for relief of occasional sleeplessness

  • Warnings

    Do not use

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

    Ask a doctor before use if

    • 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 breastfeeding,

    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 and over: Take1 softgel (50mg) at bedtime if needed, or as directed by a doctor

  • Other information

    • store at room temperature 15° to 30°C (59° to 86°F)
    • avoid excessive heat 
    • do not use if imprinted safety seal under cap is broken or missing 
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

  • Questions/Comments

    Call1-888-952-0050 (Mon-Fri 9AM-5PM EST)

  • Principal Display Panel

    Sleep Aid

    Sleep Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    sleep aid capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-052
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code PC5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-052-9696 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2023
    2NDC:21130-052-321 in 1 CARTON11/08/2023
    232 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01011/08/2023
    Labeler - Better Living Brands LLC (009137209)
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

More Info on this Drug

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