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Acetaminophen (AAA Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 500 TABLET in 1 BOTTLE, PLASTIC (57344-001-06) Label Information
TABLET 60942 TABLET in 1 CONTAINER (57344-001-99) Label Information
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (57344-001-05) > 50 TABLET in 1 BOTTLE, PLASTIC Label Information
TABLET 1000 TABLET in 1 BOTTLE, PLASTIC (57344-001-08) Label Information
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (57344-001-02) > 100 TABLET in 1 BOTTLE, PLASTIC Label Information
TABLET 100 TABLET in 1 BOTTLE, PLASTIC (57344-001-04) Label Information
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (57344-001-07) > 24 TABLET in 1 BOTTLE, PLASTIC Label Information
TABLET 100 TABLET in 1 BOTTLE, PLASTIC (57344-001-01) Label Information
TABLET 1000 TABLET in 1 BOTTLE, PLASTIC (57344-001-03) Label Information

Complete Acetaminophen Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each tablet)

    Acetaminophen 325 mg


  • Purpose

    Pain reliever/fever reducer


  • Uses

    • temporarily relieves minor aches and pains due to:
      • the common cold
      • headache
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever

  • Warnings

    Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 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.
    • if the user is allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if the user has liver disease.

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

    Stop use and ask a doctor if
    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    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 tablets every 4 to 6 hours while symptoms last
    • do not take more than 10 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
    children 6-11 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    children under 6 years
    • ask a doctor

  • Other information

    • store between 20-25°C (68-77°F)
    • retain carton for complete product information

  • Inactive ingredients

    povidone, pregelatinized starch, sodium starch glycolate, stearic acid


  • SPL UNCLASSIFIED SECTION

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


  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    RESTORE u

    NDC 57344-001-02

    †COMPARE TO THE ACTIVE
    INGREDIENT IN TYLENOL®
    REGULAR STRENGTH

    REGULAR
    STRENGTH
    CONTAINS NO ASPIRIN

    Pain Relief
    Pain Reliever, Fever Reducer

    Contains Acetaminophen

    100 TABLETS - 325 mg each

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code M2A3;57344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-001-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:57344-001-02 1 in 1 CARTON
    2 100 in 1 BOTTLE, PLASTIC
    3 NDC:57344-001-03 1000 in 1 BOTTLE, PLASTIC
    4 NDC:57344-001-04 100 in 1 BOTTLE, PLASTIC
    5 NDC:57344-001-05 1 in 1 CARTON
    5 50 in 1 BOTTLE, PLASTIC
    6 NDC:57344-001-06 500 in 1 BOTTLE, PLASTIC
    7 NDC:57344-001-07 1 in 1 CARTON
    7 24 in 1 BOTTLE, PLASTIC
    8 NDC:57344-001-08 1000 in 1 BOTTLE, PLASTIC
    9 NDC:57344-001-99 60942 in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 12/13/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 181192162 MANUFACTURE(57344-001)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 010411533 PACK(57344-001)