NOTTS - Muscle Aches and Pain

Manufacturer
VIVUNT PHARMA LLC
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:45:05

Label at a glance#

ProductNOTTS - Muscle Aches and Pain
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

For 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 1 caplets every 4 to 6 hours do not take more than 6 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each caplet)Purpose
Acetaminophen 650 mgPain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

For 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 damage may occur if you take:

● more than 4,000 mg of acetaminophen in 24 hours, which isthe 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
  • pain 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 exceed recommended dosage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 1 caplets every 4 to 6 hours
  • do not take more than 6 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.

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

* Divided into 2 intakes of one caplet every 4 hours. Use only as directed in Drug Facts.


**This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol® 8HR.

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, Florida FL 33156-3178

Made in India

PRINCIPAL DISPLAY PANEL - 24 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOTTS™ 8HR*

Muscle Aches & Pain

Acetaminophen

  • Minor Muscle Aches
  • Fever Reducer


Compare to Tylenol® 8HR active ingredients**

NDC 82706-008-01

650 mg each caplet

24 CAPLETS

Muscle and pain 24-01Muscle and pain 24-01

PRINCIPAL DISPLAY PANEL - 100 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOTTS™ 8HR*

Muscle Aches & Pain

Acetaminophen

  • Minor Muscle Aches
  • Fever Reducer


Compare to Tylenol® 8HR active ingredients**

NDC 82706-008-02

650 mg each caplet

100 CAPLETS

Muscle and pain 100-02Muscle and pain 100-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198444acetaminophen 650 MG Oral TabletPSN11
198444acetaminophen 650 MG Oral TabletSCD11
198444APAP 650 MG Oral TabletSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-008-01NOTTS - Muscle Aches and Pain1 in 1 CARTONTABLET111
82706-008-01NOTTS - Muscle Aches and Pain24 in 1 BOTTLE, PLASTICTABLET2411
82706-008-02NOTTS - Muscle Aches and Pain1 in 1 CARTONTABLET111
82706-008-02NOTTS - Muscle Aches and Pain100 in 1 BOTTLE, PLASTICTABLET10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-008NOTTS - MUSCLE ACHES AND PAIN (ACETAMINOPHEN) TABLET [VIVUNT PHARMA LLC]11Current NDC, Legacy NDC, 4 package rows20241220_e6741300-4573-2580-e053-2a95a90a599c.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
82706-00882706-008-02, 82706-008-01

Ingredients#

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

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

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 - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
ndc (package): 82706-008-02
ndc (package): 82706-008-01
ndc (product): 82706-008
ndc11 (package): 82706000802
ndc11 (package): 82706000801
spl id: 297f21bd-334d-b222-e063-6394a90ac042
spl set id: e6741300-4573-2580-e053-2a95a90a599c

Reported adverse events (FAERS/openFDA)#

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