Notts - Tension Headache

Notts - Tension Headache
SPL v4
SPL
SPL Set ID 08f2ae03-967b-ad7e-e063-6294a90a8484
Route
ORAL
Published
Effective Date 2023-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Talc D&c Red No. 27 Aluminum Lake Sodium Starch Glycolate Type A Starch, Corn Magnesium Stearate Microcrystalline Cellulose Sodium Lauryl Sulfate Povidone Croscarmellose Sodium Polacrilin Potassium

Identifiers & Packaging

Pill Appearance
Imprint: Notts;TH Shape: oval Color: red Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-30

Description

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


Medication Information

Description

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain Reliever Caffeine 65 mg Pain 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
Section 42229-5

*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

Section 55105-1

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

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

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.
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

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.
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.

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.
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.

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.

Ask A Doctor Before Use If

you have liver disease.

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.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

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


Structured Label Content

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
Section 42229-5 (42229-5)

*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

Section 55105-1 (55105-1)

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

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

Do Not Use (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.
Allergy Alert: (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

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.
Caffeine Warning: (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.

Other Information (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.
Overdose Warning: (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.

Inactive Ingredients (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.

Ask A Doctor Before Use If (Ask a doctor before use if)

you have liver disease.

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a healt professional before use.

Package Principal Display Panel Th 24 Caplets (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Package Principal Display Panel Th 100 Caplets (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


Advanced Ingredient Data


Raw Label Data

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