Label: NOTTS - TENSION HEADACHE- acetaminophen, caffeine tablet

  • NDC Code(s): 82706-010-01, 82706-010-02
  • Packager: VIVUNT PHARMA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 24, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain Reliever
    Caffeine 65 mgPain reliever Aid

  • Uses

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

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

    Liver Warning:

    Liver warning: This product contains acetaminophen.

    Severe 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 ehile using this product.

    Allergy alert:

    Acetaminophen may cause severe sking reactions. Symptoms may include:

    • skin reddening
    • rash
    • blisters.

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

    Caffeine warning:

    The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness. and occasionally, rapid heartbeat.

    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 gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition

    If pregnant or breast-feeding,

    ask a healt professional before use.

    Keep out of the 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 use more than directed
    • Do not take more than 6 caplets in 24 hours, or as directed by a doctor

    adults and children 12 years and over
    • take 2 caplets every 6 hours
    children under 12 years
    • ask a doctor

  • Other information

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

    Croscarmellose Sodium, D&C Red No.27 Aluminium Lake, Magnesium Stearate, Microcrystalline Cellulose, Polacrilin Potassium, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch, Talc.

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache Caplets.

    Distributed by: VIVUNT PHARMA LLC

    8950 SW 74th Court, Suite 1901

    Miami, FL 33156-3178

    Made in India.

    www.vivunt.live

  • Package Principal Display Panel - TH 24 Caplets

    NOTTS®

    Tension Headache

    500 mg 65 mg each caplet

    • Headaches Relief
    • Aspirin Free

    Compare to Excedrin ® Tension Headache active ingredients*

    NDC 82706-010-01

    24 CAPLETS

    TH 24

  • Package Principal Display Panel - TH 100 Caplets

    NOTTS®

    Tension Headache

    500 mg 65 mg each caplet

    Headaches Relief
    Aspirin Free

    Compare to Excedrin® Tension Headache active ingredients*

    NDC 82706-010-02

    100 CAPLETS

    TH 100

  • INGREDIENTS AND APPEARANCE
    NOTTS - TENSION HEADACHE 
    acetaminophen, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code Notts;TH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-010-011 in 1 CARTON10/30/2023
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:82706-010-021 in 1 CARTON10/30/2023
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/30/2023
    Labeler - VIVUNT PHARMA LLC (045829437)
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