NOVEX ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

Novex Acetaminophen Extra Strength by

Drug Labeling and Warnings

Novex Acetaminophen Extra Strength by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

PURPOSE

Purpose:

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses:

■ temporarily relieves minor aches and pains due to:

the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps

■ temporarily reduces fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ 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 ■ blisters ■ rash

if skin reaction occurs. stop use and seek medical help right away.

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 in this product

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 gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ 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

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
■ do not take more than directed (see overdose warning)

• adults and children 12 years and over:

  ■ take 2 caplets every 6 hours while symptoms last

  ■ do not take more than 6 caplets in 24 hours. unless 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 SAFETY INFORMATION

Other information
■ store between 20-25°C (68-77°F)
■ do not use if carton is opened or bottle inner seal is broken or missing

INACTIVE INGREDIENT

Inactive Ingredients:

Croscarmellose Sodium, Lactose Monohydrate, Microcrystalline Cellulose 102, Povidone K30, Stearic Acid, Talc, Titanium Dioxide

QUESTIONS

Questions or Comments?

Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST 

PRINCIPAL DISPLAY PANEL NDC:

44237-048-07 Novex Acetaminophen EXTRA STRENGTH Acetaminophen Pain Reliever/Fever Reducer 50 CAPLETS for Adults 500 mg each

INGREDIENTS AND APPEARANCE

NOVEX ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-048
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-048-07	1 in 1 CARTON	04/14/2020
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/14/2020

Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)

Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-048)