FDA.reportPublic FDA data

NOTTS - Extra Strength 500 mg

Manufacturer
VIVUNT PHARMA LLC
Effective date
2025-02-12
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:55:18

Label at a glance#

ProductNOTTS - Extra Strength 500 mg
Active ingredientACETAMINOPHEN
Label structure13 sections

Indications and 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

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each caplet)Purpose
Acetaminophen 500 mgPain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Liver Warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

Extra Strenght 01Extra Strenght 01

PRINCIPAL DISPLAY PANEL - 100 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

Extra Strenght 02Extra Strenght 02

PRINCIPAL DISPLAY PANEL - 400 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOTTS™

Extra Strength

Acetaminophen

  • Pain Reliever
  • Fever Reducer

NDC 82706-007-03

500 mg each caplet

400 CAPLETS

Extra Strength.

Extra Strenght 03Extra Strenght 03

PRINCIPAL DISPLAY PANEL 2 - 100 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Notts Extra Strenght 500 capletsNotts Extra Strenght 500 caplets

Principal display 50 caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOTTS™

Extra Strength

Acetaminophen

Pain Reliever
Fever Reducer


Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-06

500 mg each caplet

50 CAPLETS

Extra Strength.

25 blisters of 2 caplets each

500 mg each

5050

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN12
198440acetaminophen 500 MG Oral TabletSCD12
198440APAP 500 MG Oral TabletSY12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-007-01NOTTS - Extra Strength 500 mg1 in 1 CARTONTABLET112
82706-007-01NOTTS - Extra Strength 500 mg24 in 1 BOTTLE, PLASTICTABLET2412
82706-007-02NOTTS - Extra Strength 500 mg100 in 1 BOTTLE, PLASTICTABLET10012
82706-007-02NOTTS - Extra Strength 500 mg1 in 1 CARTONTABLET112
82706-007-03NOTTS - Extra Strength 500 mg400 in 1 BOTTLE, PLASTICTABLET40012
82706-007-04NOTTS - Extra Strength 500 mg2 in 1 POUCHTABLET212
82706-007-04NOTTS - Extra Strength 500 mg3 in 1 CARTONTABLET312
82706-007-05NOTTS - Extra Strength 500 mg2 in 1 POUCHTABLET212
82706-007-05NOTTS - Extra Strength 500 mg50 in 1 CARTONTABLET5012
82706-007-06NOTTS - Extra Strength 500 mg25 in 1 CARTONTABLET2512
82706-007-06NOTTS - Extra Strength 500 mg25 in 1 BLISTER PACKTABLET2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-007NOTTS - EXTRA STRENGTH 500 MG (ACETAMINOPHEN) TABLET [VIVUNT PHARMA LLC]12Current NDC, Legacy NDC, 11 package rows20250215_e677f43d-b4ce-e5b0-e053-2a95a90ad67e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-00782706-007-01, 82706-007-02, 82706-007-03, 82706-007-04, 82706-007-05, 82706-007-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
TALC7SEV7J4R1UIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NOTTS - Extra Strength 500 mgACETAMINOPHENVIVUNT PHARMA LLCe677f43d-b4ce-e5b0-e053-2a95a90ad67e2025-02-12WarningsExact identifier
ndc (package): 82706-007-03
ndc (package): 82706-007-06
ndc (package): 82706-007-01
ndc (package): 82706-007-04
ndc (package): 82706-007-05
ndc (package): 82706-007-02
ndc (product): 82706-007
ndc11 (package): 82706000703
ndc11 (package): 82706000701
ndc11 (package): 82706000704
ndc11 (package): 82706000705
ndc11 (package): 82706000702
ndc11 (package): 82706000706
spl id: 2df54d96-b18b-e9e3-e063-6294a90a6926
spl set id: e677f43d-b4ce-e5b0-e053-2a95a90ad67e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.