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Acetaminophen PM (SIMPLY RIGHT (Sam's West, Inc.))

Available Formats

Dosage Form Package Information Links
TABLET, COATED 500 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-213-30) 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 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 other products containing diphenhydramine, even one used on skin
    • in children under 12 years of age

    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 serious underlying medical illness.
    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 10 days 
    • fever gets worse or lasts more than 3 days

    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. 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

    Other information
    • store at room temperature 15º-30ºC (59º-86ºF)
    • avoid high humidity and excessive heat

  • Inactive ingredients

    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*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, titanium dioxide, triacetin*

    *contains one or more of these ingredients


  • Questions or comments?

    Call toll free 1-888-301-0332 Monday-Friday 8AM-5PM CST


  • Principal Display Panel

    nighttime pain reliever

    extra strength

    acetaminophen PM

    acetaminophen 500 mg

    diphenhydramine HCl 25 mg

    **Compare to Extra Strength Tylenol® PM active ingredients

    Pain reliever

    Nighttime Sleep Aid

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

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

    Distributed by:

    SAM'S West, Inc.

    Bentonville, AR  72716


  • Product Label

    Acetaminophen 500 mg; Diphenhydramine HCl 25 mg

    Simply Right Extra Strength Acetaminophen PM Caplet


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-213
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code S525;CPC752
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-213-30 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/30/2013
    Labeler - SIMPLY RIGHT (Sam's West, Inc.) (051957769)
    Registrant - P and L Development of New York Corporation (800014821)