NOTTS - Muscle Aches and Pain

Generic name: Acetaminophen

VIVUNT PHARMA LLC

Dosage Form

N/A

Manufacturer

VIVUNT PHARMA LLC

Active ingredient

ACETAMINOPHEN650 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

82706-008-01
82706-008-02

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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.

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

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Active ingredient

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.

Do not use if…Keep out of reach of children.

Ask a doctor before use 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.

Ask a doctor or pharmacist before use if…the blood thinning drug warfarin

Stop use and talk to a doctor if…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 in…

Storage and handlingStore 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.

Package labelNOTTS™ 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

Package labelNOTTS™ 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

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

Liver Warning

Allergy Alert

Overdose warning

SPL UNCLASSIFIED SECTION

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