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#
Contacts and useful links#
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
Products#
Every source-derived product name is available through these pages.
- Novex Acetaminophen Extra Strength
- Acetaminophen
- LACTOSE MONOHYDRATE
- MICROCRYSTALLINE CELLULOSE 102
- CROSCARMELLOSE SODIUM
- POVIDONE K30
- TALC
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 44237-048 | 44237-048-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MICROCRYSTALLINE CELLULOSE 102 | PNR0YF693Y | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| TALC | 7SEV7J4R1U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 97028648-cbf9-42df-b506-3bcf02b8dd43 | e90270d6-05b2-423d-897f-9190bd13a5e6 | 2021-08-06 | Warnings | e90270d6-05b2-423d-897f-9190bd13a5e6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
