NOTTS - EXTRA STRENGTH 500 MG- acetaminophen tablet

NOTTS - Extra Strength 500 mg by

Drug Labeling and Warnings

NOTTS - Extra Strength 500 mg by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredient (in each caplet): Purpose
• Acetaminophen 500 mg: Pain 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

• Do not take more than directed (see overdose warning)

• 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 years: ask a doctor

Other information

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

Inactive ingredients

Croscarmellose Sodium, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Sodium Starch Glycolate, Talc, Titanium Dioxide.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol®Extra Strength.

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178

Made in India

PRINCIPAL DISPLAY PANEL - 24 Caplets

NOTTS™

Extra Strength

Acetaminophen

• Pain Reliever
• Fever Reducer

Compare to Tylenol® Extra Strength active ingredients*

NDC: 82706-007-01

500 mg each caplet

24 CAPLETS

Extra Strength.

PRINCIPAL DISPLAY PANEL - 100 Caplets

NOTTS™

Extra Strength

Acetaminophen

• Pain Reliever
• Fever Reducer

Compare to Tylenol® Extra Strength active ingredients*

NDC: 82706-007-02

500 mg each caplet

100 CAPLETS

Extra Strength.

PRINCIPAL DISPLAY PANEL - 400 Caplets

NOTTS™

Extra Strength

Acetaminophen

• Pain Reliever
• Fever Reducer

NDC: 82706-007-03

500 mg each caplet

400 CAPLETS

Extra Strength.

PRINCIPAL DISPLAY PANEL 2 - 100 Caplets

NOTTS™

Extra Strength

Acetaminophen

Pain Reliever
Fever Reducer

Compare to Tylenol® Extra Strength active ingredients*

NDC: 82706-007-05

500 mg each caplet

100 CAPLETS

Extra Strength.

50 pouches of 2 caplets each

500 mg each

INGREDIENTS AND APPEARANCE

NOTTS - EXTRA STRENGTH 500 MG 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-007
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
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
Color	white	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	Notts;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-007-01	1 in 1 CARTON	08/17/2022
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 82706-007-02	1 in 1 CARTON	08/17/2022
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 82706-007-03	400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2022
4	NDC: 82706-007-04	3 in 1 CARTON	09/20/2023	09/20/2023
4		2 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 82706-007-05	50 in 1 CARTON	07/05/2024
5		2 in 1 POUCH; 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	08/17/2022

Labeler - VIVUNT PHARMA LLC (045829437)