NOTTS - Muscle Aches & Pain
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Active ingredient (in each caplet) | Purpose |
| Acetaminophen 650 mg | Pain Reliever/Fever Reducer |
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
Warnings
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:
If a skin reaction occurs, stop use and seek medical attention immediately.
- skin reddening
- rash
- blisters
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
Ask a doctor or pharmacist before use if you are taking
the blood thinning drug warfarin
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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
If pregnant or breast-feeding,
ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
| adults and children 12 years and over | take 1 caplets every 4 to 6 hoursdo not take more than 6 caplets in 24 hours, or as directed by a doctordo not use for more than 10 days unless directed by a doctor |
| children under 12 years | ask a doctor |
- Do not take more than directed (see overdose warning)
Other information
- 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
Corn Starch, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Stearic Acid, Sodium Starch Glycolate, Soy Lecithin, 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.
Product of China
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th Court, Suite 1901
Miami, Florida Z.C. 33156-3175