Label: NOTTS - EXTRA STRENGTH 500 MG- acetaminophen tablet

  • NDC Code(s): 82706-007-01, 82706-007-02, 82706-007-03, 82706-007-04
  • Packager: VIVUNT PHARMA LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 3, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)Purpose
    Acetaminophen 500 mgPain Reliever/Fever Reducer

  • Uses

    Temporary relief of minor aches and pains due to:

    ● common cold
    ● headache
    ● toothache
    ● muscular aches
    ● backaches
    ● premenstrual and menstrual cramps
    ● minor pain from arthritis

    Temporarily reduces fever

  • 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, which is the maximum daily amount.
    • 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
    • rash
    • blisters

    If a skin reaction occurs, stop use and seek medical attention immediately.

    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.

    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 lasts more than 10 days
    • fever lasts more than 3 days
    • pain or fever gets worse
    • 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

    Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt 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
    • do not take more than 8 caplets in 24 hours, or as directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 yearsask a doctor
  • Other information

    • Store between 20-25°C (68-77°F)
    • Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
    • Tamper-evident: Do not use if the bottle cap is open or if the foil inner seal is broken or missing.
  • Inactive ingredients

    Corn Starch, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Stearic Acid, Sodium Starch Glycolate, Soy Lecithin, Talc, Titanium Dioxide.

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol®Extra Strength.

    Product of China

    Distributed by:

    VIVUNT PHARMA LLC

    8950 SW 74th Court, Suite 1901

    Miami, Florida Z.C. 33156-3175

  • PRINCIPAL DISPLAY PANEL - 24 Caplets

    NOTTS™

    Extra Strength

    Acetaminophen

    • Pain Reliever
    • Fever Reducer


    Compare to Tylenol® Extra Strength active ingredients*

    NDC 82706-007-01

    500 mg each caplet

    24 CAPLETS

    Extra Strength.

    Label Notts Extra Strenght 500 mg x 24 caplets - 01

  • PRINCIPAL DISPLAY PANEL - 100 Caplets

    NOTTS™

    Extra Strength

    Acetaminophen

    • Pain Reliever
    • Fever Reducer


    Compare to Tylenol® Extra Strength active ingredients*

    NDC 82706-007-02

    500 mg each caplet

    100 CAPLETS

    Extra Strength.

    Label Notts Extra Strenght 500 mg x 100 caplets - 02

  • PRINCIPAL DISPLAY PANEL - 400 Caplets

    NOTTS™

    Extra Strength

    Acetaminophen

    • Pain Reliever
    • Fever Reducer

    NDC 82706-007-03

    500 mg each caplet

    400 CAPLETS

    Extra Strength.

    Label Notts Extra Strenght x 500 caplets - 03

  • INGREDIENTS AND APPEARANCE
    NOTTS - EXTRA STRENGTH 500 MG 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code Notts;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-007-011 in 1 CARTON08/17/2022
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:82706-007-021 in 1 CARTON08/17/2022
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:82706-007-03400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2022
    4NDC:82706-007-043 in 1 CARTON09/20/202309/20/2023
    42 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/17/2022
    Labeler - VIVUNT PHARMA LLC (045829437)
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