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Acetaminophen PM (AAA Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-095-06) Label Information
TABLET, COATED 100 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-095-08) Label Information
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 150 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-095-04) Label Information
TABLET, COATED 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-095-07) Label Information
TABLET, COATED 2 BOTTLE, PLASTIC in 1 CARTON (57344-095-09) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, COATED 300 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-095-12) Label Information
TABLET, COATED 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-02) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC Label Information

Complete Acetaminophen PM Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients
    (in each caplet)
    Purpose
    Acetaminophen 500 mg Pain reliever
    Diphenhydramine HCl 25 mg Nighttime sleep aid

  • Uses

    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
    • 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.
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts 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

    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 between 20-25°C (68-77°F) in a dry place
    • retain carton for complete product information

  • Inactive ingredients

    colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048


  • PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton

    RESTORE u

    NDC 57344-095-03

    †COMPARE TO THE
    ACTIVE INGREDIENTS
    IN TYLENOL® PM

    EXTRA
    STRENGTH

    Non-habit forming

    Pain Relief PM

    Pain Reliever, Nighttime Sleep Aid

    Acetaminophen
    Diphenhydramine HCI

    100 CAPLETS

    Principal Display Panel - 100 Caplet Bottle Carton

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN PM 
    acetaminophen and diphenhydramine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-095
    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)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code AAA;1031
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-095-01 1 in 1 CARTON
    1 24 in 1 BOTTLE, PLASTIC
    2 NDC:57344-095-02 1 in 1 CARTON
    2 50 in 1 BOTTLE, PLASTIC
    3 NDC:57344-095-03 1 in 1 CARTON
    3 100 in 1 BOTTLE, PLASTIC
    4 NDC:57344-095-04 150 in 1 BOTTLE, PLASTIC
    5 NDC:57344-095-06 500 in 1 BOTTLE, PLASTIC
    6 NDC:57344-095-07 1000 in 1 BOTTLE, PLASTIC
    7 NDC:57344-095-08 100 in 1 BOTTLE, PLASTIC
    8 NDC:57344-095-09 2 in 1 CARTON
    8 100 in 1 BOTTLE, PLASTIC
    9 NDC:57344-095-12 300 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 12/13/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 181192162 MANUFACTURE(57344-095)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 010411533 PACK(57344-095)