Label: GOOD SENSE SLEEP TIME- diphenhydramine hcl capsule, liquid filled

  • NDC Code(s): 0113-0052-53, 0113-0052-62, 0113-0052-67
  • Packager: L. Perrigo Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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  • Active ingredient (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

    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
    •
    difficulty in urination due to an enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    •
    avoid alcoholic beverages

    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.

    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)
     
    adults & children 12 yrs & over

    2 softgels at bedtime if needed or as directed by a doctor
     
    children under 12 yrs

    do not use

    Other information

    •
    store at 20-25°C (68-77°F)
    •
    avoid excessive heat above 40°C (104°F)
    •
    protect from light
  • Inactive ingredients

    edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

    Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Non-Habit Forming

    Sleep Time

    Nighttime Sleep-Aid

    Actual Size

    Diphenhydramine HCl 25 mg

    Not For Treating Cold or Flu

    See Warnings

    Compare to active ingredient of Vicks® ZzzQuil® LiquiCaps®

    100% SATISFACTION GUARANTEED

    12 Softgels

    052C2-sleep-time.jpg
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE SLEEP TIME 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0052
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 052
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0052-536 in 1 CARTON02/06/201407/31/2025
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0113-0052-6212 in 1 CARTON02/06/201409/01/2015
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0113-0052-6724 in 1 CARTON05/13/201909/30/2023
    32 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01002/06/201407/31/2025
    Labeler - L. Perrigo Company (006013346)
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