FDA Label for Notts - Muscle Aches And Pain

Other

Drug Facts

Product of China

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, Florida Z.C. 33156-3175

Otc - Purpose

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

Liver Warning

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

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
• 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,

ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

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

• 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

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.

Inactive Ingredients

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.

Principal Display Panel - 24 Caplets

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

* 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.

Principal Display Panel - 100 Caplets

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

* 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