Label: BASIC CARE NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 19, 2019

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

  • 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 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

    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 at 20-25°C (68-77°F)
  • Inactive ingredients

    edible ink*, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Unisom® SleepGels® active ingredient

    Non-Habit Forming

    nighttime sleep-aid

    Diphenhydramine HCl Softgels, 50 mg

    actual size

    One softgel per dose

    96 SOFTGELS

    5v6-an-nighttime-sleep-aid.jpg
  • INGREDIENTS AND APPEARANCE
    BASIC CARE NIGHTTIME SLEEP AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-7506
    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 (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUE (clear to light blue) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code 5V6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-7506-801 in 1 CARTON08/15/2019
    196 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33808/15/2019
    Labeler - L. Perrigo Company (006013346)