Other
Drug Facts
Product of China
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, Florida Z.C. 33156-3175
Notts - Extra Strength 500 Mg Tablet
FDA Label NDC 82706-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Notts - Extra Strength 500 Mg (NDC 82706-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
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
- a sodium restricted diet
- kidney disease
- a magnesium restricted diet
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
Do not take more than recommended. 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)
- 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
| adults and children 12 years and over | |
| children under 12 years | ask a doctor |
Other Information
- Store between 20-25°C (68-77°F)
- Each caplet contains: sodium 9 mg and magnesium 75 mg.
- 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
Aluminum Oxide, Carnauba Wax, Cellulose Powder, Corn Starch, FD&C Red No. 40, Hypromellose, Magnesium Stearate, Polyethylene Glycol, Propylene Glycol, Shellac, Sodium Starch Glycolate Type A, Titanium Dioxide.
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
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademarks Tylenol ® 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
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademarks Tylenol ® Extra Strength.
Principal Display Panel - 400 Caplets
NOTTS™
Extra Strength
Acetaminophen
- Pain Reliever
- Fever Reducer
Compare to Tylenol® Extra Strength active ingredients*
NDC 82706-007-03
500 mg each caplet
400 CAPLETS
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademarks Tylenol ® Extra Strength.
* Please review the disclaimer below.
