Label: GOOD SENSE NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 0113-0431-62, 0113-0431-68
  • Packager: L. Perrigo Company
  • 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 May 21, 2019

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

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    for relief of occasional sleeplessness

  • Warnings

    Do not use

    in 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
    trouble urinating due to an enlarged prostate gland
    glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    avoid alcoholic drinks
    drowsiness may occur
    do not drive a motor vehicle or operate machinery

    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 and over

    take 2 caplets at bedtime if needed, or as directed by a doctor

    children under 12 years

    do not use

  • Other information

    each caplet contains: calcium 15 mg
    store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
    do not use if blister unit is broken or torn
  • Inactive ingredients

    carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Pain Reliever Free

    Nighttime Sleep Aid

    #1 DOCTOR RECOMMENDED sleep-aid active ingredient

    Diphenhydramine HCl 25 mg

    Actual Size

    Helps You Fall Asleep

    Non-Habit Forming

    Compare to active ingredient of Simply Sleep® Nighttime Sleep Aid Caplets

    24 Caplets

    GoodSense Nighttime Sleep Aid
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE NIGHTTIME SLEEP AID 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0431
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (Light Blue) Scoreno score
    ShapeOVALSize11mm
    FlavorImprint Code L431
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0431-6212 in 1 CARTON04/25/2001
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0113-0431-6818 in 1 CARTON05/21/2019
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33804/25/2001
    Labeler - L. Perrigo Company (006013346)