NDC 44237-047 Novex Diphenhydramine

Diphenhydramine Hydrochloride

NDC Product Code 44237-047

NDC CODE: 44237-047

Proprietary Name: Novex Diphenhydramine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Diphenhydramine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Shape: ROUND (C48348)
Score: 1

NDC Code Structure

  • 44237 - Herbion Pakistan (pvt.) Ltd

NDC 44237-047-06

Package Description: 3 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Novex Diphenhydramine with NDC 44237-047 is a a human over the counter drug product labeled by Herbion Pakistan (pvt.) Ltd. The generic name of Novex Diphenhydramine is diphenhydramine hydrochloride. 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 Diphenhydramine 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 25 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.

  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • TALC (UNII: 7SEV7J4R1U)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)

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: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-09-2020 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 Diphenhydramine Product Label Images

Novex Diphenhydramine 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 tablet)Diphenhydramine HCl 25mg

Otc - Purpose

PurposeAntihistamine

Indications & Usage

  • UsesTemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingrunny nose itchy, watery eyes itching of the nose or throatTemporarily relieves these symptoms due to the common cold:runny nosesneezing

Warnings

  • WarningsDo not useto make a child sleepywith any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you havea breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizersWhen using this productmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in childrenIf pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Dosage & Administration

  • Directionstake every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursadults and children 12 years and over1 to 2 tabletchildren 6 to under 12 years1 tabletchildren under 6 yeardo not use

Other Safety Information

Other Information:■ store between 68-77°F (20-25°C). Protect from light.■ Do not use if blister unit is broken.

Inactive Ingredient

Inactive Ingredients:Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Carboxymethyl Cellulose Sodium, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Methacrylic Acid Co-Polymer, Talc, FD&C Blue No.1, Indigo Caramine.

Otc - Questions

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

* Please review the disclaimer below.