NOTTS - MUSCLE ACHES AND PAIN- acetaminophen tablet

NOTTS - Muscle Aches and Pain by

Drug Labeling and Warnings

NOTTS - Muscle Aches and Pain by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• 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:

• 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

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

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)
• Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.

Inactive ingredients

Croscarmellose Sodium, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Sodium Starch Glycolate, 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.

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, Florida FL 33156-3178

Made in India

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

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

INGREDIENTS AND APPEARANCE

NOTTS - MUSCLE ACHES AND PAIN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Notts;650
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-008-02	1 in 1 CARTON	08/17/2022
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 82706-008-01	1 in 1 CARTON	08/17/2022
2		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/17/2022

Labeler - VIVUNT PHARMA LLC (045829437)