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Pill Identifier Information of APAP 500 MG Oral Tablet

Drug Information

APAP 500 MG Oral Tablet

Imprint: GPI;A5
Shape: C48345
Color: C48325
Ingredients: Acetaminophen
Size: 17.00
Score: 1
Rxtty: SY
Author: Bonita Pharmaceuticals LLC
Inactive Ingredients: POVIDONE / STARCH, PREGELATINIZED CORN / SODIUM STARCH GLYCOLATE TYPE A CORN / STEARIC ACID>

Complete 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53598-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL ((Capsule Shaped Tablets)) Size17mm
    FlavorImprint Code GPI;A5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53598-003-01100 in 1 BOTTLE, PLASTIC
    2NDC:53598-003-101000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/02/2013
    Labeler - Bonita Pharmaceuticals LLC (004219442)
    Registrant - Bonita Pharmaceuticals LLC (004219442)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bonita Pharmaceuticals LLC004219442label(53598-003)
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