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Acetaminophen PM (Kareway Product, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 BOX (67510-0154-2) > 24 TABLET in 1 BOTTLE Label Information

Complete Acetaminophen PM Information

  • Active Ingredients (in each caplet)

    Acetaminophen 500mg

    Diphenhydramine HCl 25mg


  • Purpose

    Pain reliever

    Nighttime sleep aid


  • Uses

    temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessnes


  • Warnings

    • Warnings

    Liver warning:

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

    • more than 4,000ms 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 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
    • drowsiness will occur
    • avoid alcoholic drinks
    • 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
    • pain gets worse or lasts more than 10 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.

    Enter section text here

    Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center right away.  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 take more than directed (see overdose warning)

    adults and children under 12 years and over
    • take 2 caplets at bedtime
    • do not take more than 2 caplets of this product in 24 hours
    children under 12 years
    do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage


  • Other information

    • do not use if safety seal under cap is broken or missing
    • store between 20-25°C (68-77°F)
    • see end panel for lot number and expiration date

  • Inactive ingredients

    corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide



  • PRINCIPAL DISPLAY PANEL

    non-aspirin PM

    image of carton label


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN PM 
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0154
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color blue (blue) Score no score
    Shape ROUND Size 17mm
    Flavor Imprint Code PM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0154-2 1 in 1 BOX
    1 24 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/28/2011
    Labeler - Kareway Product, Inc. (121840057)