Label: EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet

  • NDC Code(s): 57896-204-01, 57896-204-05, 57896-204-10, 57896-204-20
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Acetaminophen 500 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    • temporarily relieves minor aches and pains
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if you take:

    • more than 8 tablets (4,000 mg of acetaminophen) in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: acetaminophen may cause severe skin reactions.
    Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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.

    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 symptom 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. 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
    • adults and children 12 years and over: Take 1-2 tablets every 4-6 hours, as needed; not more than 6 tablets in 24 hours. Do
      not take for more than 10 days unless directed by a doctor.
    • children under 12 years: ask a doctor
  • Other Information

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
    • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • Inactive Ingredients

    povidone, sodium starch glycolate, starch, stearic acid.

  • Questions or comments?

    1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUND (Round) Size12mm
    FlavorImprint Code AZ011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-204-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2018
    2NDC:57896-204-20200 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2018
    3NDC:57896-204-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2018
    4NDC:57896-204-0550 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2018
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)