NOTTS - TENSION HEADACHE- acetaminophen, caffeine tablet

NOTTS - Tension Headache by

Drug Labeling and Warnings

NOTTS - Tension Headache by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

• 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

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

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

INGREDIENTS AND APPEARANCE

NOTTS - TENSION HEADACHE 
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	Notts;TH
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-010-01	1 in 1 CARTON	10/30/2023
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 82706-010-02	1 in 1 CARTON	10/30/2023
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	10/30/2023

Labeler - VIVUNT PHARMA LLC (045829437)