GOOD SENSE HEADACHE PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY]

  • Home
  • GOOD SENSE HEADACHE PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY]

GOOD SENSE HEADACHE PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L. PERRIGO COMPANY]
PDF | XML
NDC 0113-0355-71
Set ID b776726d-e42f-4307-a6a9-d3b0d190fe18
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART338
View All Sections
  • Active ingredients (in each tablet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • Purposes

    Pain reliever

    Nighttime sleep-aid

  • Uses

    •
    for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    •
    skin reddening
    •
    blisters
    •
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    •
    if you have ever had an allergic reaction to this product or any of its ingredients
    •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    •
    with any other product containing diphenhydramine, even one used on skin
    •
    in children under 12 years of age

    Ask a doctor before use if you have

    •
    liver disease
    •
    glaucoma
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    •
    taking the blood thinning drug warfarin
    •
    taking sedatives or tranquilizers

    When using this product

    •
    avoid alcoholic drinks
    •
    drowsiness may occur
    •
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    •
    sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    •
    pain gets worse or lasts for more than 10 days
    •
    fever gets worse or lasts for more than 3 days
    •
    redness or swelling is present
    •
    new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not use more than directed (see overdose warning)
    •
    adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor
    •
    do not take more than 2 tablets of this product in 24 hours
    •
    children under 12 years of age: do not use
  • Other information

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

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Aspirin Free

    Headache PM

    Acetaminophen/Diphenhydramine HCl

    Pain Reliever/Nighttime Sleep-Aid

    50 Tablets

    For Adults

    Non-Habit Forming

    100% SATISFACTION GUARANTEED

    headache-pm-image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE HEADACHE PM 
    acetaminophen, diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0355
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUND (shallow convex) Size11mm
    FlavorImprint Code L355;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0355-711 in 1 CARTON09/12/1996
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/12/1996
    Labeler - L. Perrigo Company (006013346)
View All Sections

Related Drugs

Search DailyMed Drugs