NDC 37205-213 Leader Fiber

Calcium Polycarbophil

NDC Product Code 37205-213

NDC Code: 37205-213

Proprietary Name: Leader Fiber 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: Calcium Polycarbophil 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

Color(s):
BROWN (C48332 - LIGHT)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
RP120
Score: 2

NDC Code Structure

  • 37205 - Cardinal Health

NDC 37205-213-75

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Leader Fiber with NDC 37205-213 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Fiber is calcium polycarbophil. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Cardinal Health

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.

Leader Fiber 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.

  • CALCIUM POLYCARBOPHIL 625 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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • CARAMEL (UNII: T9D99G2B1R)
  • CROSPOVIDONE (UNII: 68401960MK)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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.

Product Labeler Information

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

Labeler Name: Cardinal Health
Labeler Code: 37205
FDA Application Number: part334 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: 08-19-2019 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: 12-31-2020 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.

Leader Fiber 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

Active Ingredient (In Each Caplet)

Calcium polycarbophil 625 mg

Purpose

Bulk-forming laxative

Uses

  • Relieves:constipationhelps restore & maintain regularitypromotes normal function of the bowel

Warnings

  • Do not use if you have abdominal pain, nausea or vomitingyou have difficulty in swallowingyou have noticed a sudden change in bowel habits that persists over a period of 2 weeks Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking.

Stop Use And Ask A Doctor If

  • You experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowingyou fail to have a bowel movement after userectal bleeding occurssymptoms persist more than 1 weekDrug interaction precaution: Contains calcium. If you are taking any form of tetracycline antibiotic, this product should be taken 1 hour before or 2 hours after you have taken the antibiotic

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take this product (child or adult dose) with a full glass of water (8oz)daily maximum 4 doses dosage may vary according to diet, exercise, previous laxative use or severity of constipationcontinued use for 1 to 3 days is normally required to provide full benefitadults and children 12 years of age and over2 caplets once a dayup to 4 times a daychildren under 12 yearsconsult a physician

Other Information

  • Each caplet contains: calcium 122 mgdo not use if printed seal under cap is torn or missingstore at room temperatureprotect contents from moisture

Inactive Ingredients

Calcium carbonate, caramel, crospovidone, hypromellose, maltodextrin, microcrystalline cellulose, magnesium stearate, methylcellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

* Please review the disclaimer below.