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
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 20, 2023

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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

  • PRINCIPAL DISPLAY PANEL - 6 Caplets

    NOTTS™

    Extra Strength

    Acetaminophen

    Pain Reliever
    Fever Reducer

    NDC 82706-007-03

    500 mg each caplet

    400 CAPLETS

    Extra Strength

    Extra Strength

  • 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 CARTON09/20/2023
    42 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/17/2022
    Labeler - VIVUNT PHARMA LLC (045829437)
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