GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]

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GOOD SENSE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]
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NDC 0113-0431-62
Set ID ba2adc30-0301-4d53-bce6-fc8b7e34b076
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART338
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  • 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)
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