NOTTS - EXTRA STRENGTH 500 MG- acetaminophen tablet 
VIVUNT PHARMA LLC

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NOTTS - Extra Strength 500 mg

Drug Facts

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

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

Inactive ingredients

Corn Starch, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Stearic Acid, Sodium Starch Glycolate, Soy Lecithin, Talc, Titanium Dioxide.

*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


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


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

NDC 82706-007-03

500 mg each caplet

400 CAPLETS

Extra Strength.

Label Notts Extra Strenght x 500 caplets - 03

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 CARTON09/20/202309/20/2023
42 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/17/2022
Labeler - VIVUNT PHARMA LLC (045829437)

Revised: 6/2024
Document Id: 1a0569ac-9a6f-a7b6-e063-6394a90affe3
Set id: e677f43d-b4ce-e5b0-e053-2a95a90ad67e
Version: 7
Effective Time: 20240603
 
VIVUNT PHARMA LLC