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Acetaminophen (Bonita Pharmaceuticals LLC)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 100 TABLET, COATED in 1 BOTTLE, PLASTIC (53598-003-01) Label Information
TABLET, COATED 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (53598-003-10) Label Information

Complete Acetaminophen Information

  • Active Ingredient

    (in each caplet)

    Acetaminophen 500mg


  • Purposes

    Pain reliever/Fever reducer


  • Uses

    For the temporary relief of minor aches and pains due to:

    • Headache
    • Muscular aches
    • Backache
    • Minor pain of arthritis
    • The common cold
    • Toothache
    • Premenstrual and menstrual cramps

    Temporarily reduces fever.


  • Warnings

    Liver warning:

    This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000mg) in 24 hours. Severe liver damage may occur if you take

    • more than 4,000mg 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.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have

    liver disease.

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is pressent

    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:

    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 every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor

    Children under 12years: ask a doctor


  • Other Information

    • Do not use if imprinted safety seal under cap is broken or missing
    • Store at room temperature

  • Inactive Ingredients

    • Povidone
    • Pregelatinized Starch
    • Sodium Starch Glycolate
    • Stearic Acid

  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.


  • PRINCIPAL DISPLAY PANEL

    Extra Strength Acetaminophen 500mg, 1000ct caplets

    Image 1 : Extra Strength Acetaminophen 500mg, 1000ct caplets

    Extra Strength Acetaminophen 500mg, 100ct caplets

    Image 2 : Extra Strength Acetaminophen 500mg, 100ct caplets


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53598-003
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape OVAL ((Capsule Shaped Tablets)) Size 17mm
    Flavor Imprint Code GPI;A5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53598-003-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:53598-003-10 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/02/2013
    Labeler - Bonita Pharmaceuticals LLC (004219442)
    Registrant - Bonita Pharmaceuticals LLC (004219442)
    Establishment
    Name Address ID/FEI Business Operations
    Bonita Pharmaceuticals LLC 004219442 label(53598-003)