Novex Acetaminophen Extra Strength

Manufacturer
Herbion Pakistan (Pvt.) Ltd
Effective date
2020-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:35:45

Label at a glance#

ProductNovex Acetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose:

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

Inactive Ingredients:

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Novex Acetaminophen capletNovex Acetaminophen caplet

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44237-04844237-048-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
97028648-cbf9-42df-b506-3bcf02b8dd43e90270d6-05b2-423d-897f-9190bd13a5e62021-08-06WarningsExact identifier
spl set id: e90270d6-05b2-423d-897f-9190bd13a5e6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.