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headache pm (HyVee Inc)

Available Formats

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TABLET, FILM COATED 1 BOTTLE in 1 CARTON (42507-355-71) > 50 TABLET, FILM COATED in 1 BOTTLE Label Information

Complete headache pm Information

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

    (equiv. to Diphenhydramine citrate 38 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

    Do not use
    • 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
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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.

    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 Liver 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

    Compare to Excedrin® PM Tablets active ingredients

    HEADACHE PM FORMULA

    ADDED STRENGTH

    Pain Reliever - Nighttime Sleep Aid

    Acetaminophen

    Diphenhydramine HCl

    Headache PM Formula Carton Image 1
    Headache PM Formula Carton Image 2

  • INGREDIENTS AND APPEARANCE
    HEADACHE PM  FORMULA
    acetaminophen, diphenhydramine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-355
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND (shallow convex) Size 11mm
    Flavor Imprint Code L355;PM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-355-71 1 in 1 CARTON
    1 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 08/30/1998
    Labeler - HyVee Inc (006925671)