NDC 44237-048 Novex Acetaminophen Extra Strength

Acetaminophen

NDC Product Code 44237-048

NDC 44237-048-07

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Novex Acetaminophen Extra Strength with NDC 44237-048 is a a human over the counter drug product labeled by Herbion Pakistan (pvt.) Ltd. The generic name of Novex Acetaminophen Extra Strength is acetaminophen. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Herbion Pakistan (pvt.) Ltd

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Novex Acetaminophen Extra Strength Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 500 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Herbion Pakistan (pvt.) Ltd
Labeler Code: 44237
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-14-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Novex Acetaminophen Extra Strength Product Label Images

Novex Acetaminophen Extra Strength Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Drug FactsActive ingredient (in each caplet)Acetaminophen 500 mg

Otc - 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

WarningsLiver 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 productAllergy 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 productAsk a doctor before use if you have liver diseaseAsk a doctor or pharmacist before use if you are taking the blood thinning drug warfarinStop 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 presentThese 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

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 doctorchildren under 12 yearsask 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

Otc - Questions

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

* Please review the disclaimer below.