Other
Drug Facts
Product of China
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, Florida Z.C. 33156-3175
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Notts - Muscle Aches And Pain (NDC 82706-008). 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.
Drug Facts
Product of China
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, Florida Z.C. 33156-3175
| Active ingredient (in each caplet) | Purpose |
| Acetaminophen 650 mg | Pain Reliever/Fever Reducer |
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
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
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical attention immediately.
the blood thinning drug warfarin
These could be signs of a serious condition.
ask a health professional before use
Keep out of reach of children.
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.
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Carnauba Wax, Crospovidone, FD&C Red No. 40, Hypromellose, Magnesium Stearate, Medium Chain Triglycerides, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Propylene Glycol, Shellac Glaze, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide.
NOTTS™ 8HR*
Muscle Aches & Pain
Acetaminophen
Compare to Tylenol® 8HR active ingredients**
NDC 82706-008-01
650 mg each caplet
24 CAPLETS
* Divided in 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 trademarks Tylenol ® 8HR.
NOTTS™ 8HR*
Muscle Aches & Pain
Acetaminophen
Compare to Tylenol® 8HR active ingredients**
NDC 82706-008-02
650 mg each caplet
100 CAPLETS
* Divided in 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 trademarks Tylenol ® 8HR
* Please review the disclaimer below.