NOTTS - TENSION HEADACHE- acetaminophen, caffeine tablet 
VIVUNT PHARMA LLC

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NOTTS - Tension Headache

Drug Facts

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:

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

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

Other information

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.

*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

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

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)

Revised: 11/2023
Document Id: 0aeeedc8-dcb9-087d-e063-6394a90ad1f5
Set id: 08f2ae03-967b-ad7e-e063-6294a90a8484
Version: 4
Effective Time: 20231124
 
VIVUNT PHARMA LLC