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Acetaminophen PM (BJWC (Berkley & Jensen / BJ's))

Available Formats

Dosage Form Package Information Links
TABLET, COATED 500 TABLET, COATED in 1 BOTTLE (68391-161-05) Label Information

Complete Acetaminophen PM Information

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg


  • Purpose

    Pain reliever

    Nighttime sleep-aid


  • Uses

    Temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness.


  • Warnings

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

    • more than 2 caplets in 24 hours, which is the maximum daily amount
    • 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 other products 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
    • 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 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 a 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

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

    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 (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 take more than directed (see overdose warning)
     adults and children 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

    • store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat

  • Inactive ingredients

    colloidal silicon dioxide*, croscarmellose sodium*, D&C Yellow #10 Aluminum Lake*, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol, polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

    *contains one or more of these ingredients
  • Questions or comments?

     Call toll free: 1-800-934-1204 Monday-Friday 9AM-5PM EST


  • Principal Display Panel

    PAIN RELIEVER/NIGHTTIME SLEEP-AID

    EXTRA STRENGTH

    NON-ASPIRIN PM

    ACETAMINOPHEN 500 mg

    DIPHENHYDRAMINE HCl 25 mg

    Compare to the active ingredients of Tylenol® PM Caplets**

    CAPLETS

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM.

    Distributed by BJWC

    25 Research Drive

    Westborough, MA  01581

    1-800-934-1204


  • Package Label

    ACETAMINOPHEN 500 mg, DIPHENHYDRAMINE 25 mg

    BERKLEY & JENSEN EXTRA STRENGTH NON-ASPIRIN PM CAPLETS

     


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-161
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TRIACETIN (UNII: XHX3C3X673)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 7mm
    Flavor Imprint Code S525;CPC752
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68391-161-05 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 01/15/2013
    Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)
    Registrant - P and L Development of New York Corporation (800014821)