NDC 36800-465 Fiber Laxative
Calcium Polycarbophil Tablet Oral

Product Information

What is NDC 36800-465?

The NDC code 36800-465 is assigned by the FDA to the product Fiber Laxative which is a human over the counter drug product labeled by Topco Associates, Llc. The generic name of Fiber Laxative is calcium polycarbophil. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 36800-465-27 90 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code36800-465
Proprietary Name 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.
Fiber Laxative
Non-Proprietary Name 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.
Calcium Polycarbophil
Product Type 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.
Human Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
Topco Associates, Llc
Labeler Code36800
FDA Application Number 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.
part334
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-01-2020
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Fiber Laxative?


Product Characteristics

Color(s)WHITE (C48325 - OFF WHITE)
ShapeCAPSULE (C48336)
Size(s)18 MM
Imprint(s)G147
Score1

Product Packages

NDC Code 36800-465-27

Package Description: 90 TABLET in 1 BOTTLE

Product Details

What are Fiber Laxative Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Fiber Laxative Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 308934 - calcium polycarbophil 625 MG Oral Tablet
  • RxCUI: 308934 - calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet

Fiber Laxative Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Fiber Laxative Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (In Each Caplet)



Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil


Purpose



Bulk-forming laxative


Use(S)



  • relieves occasional constipation
  • this product generally produces bowel movement in 12 to 72 hours

Warnings



Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.


Ask A Doctor Before Use If You Have



  • abdominal pain, nausea or vomiting
  • difficulty in swallowing
  • a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are



taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.


When Using This Product



  • do not use for more than 7 days unless directed by a doctor
  • do not take more than 8 caplets in a 24 hour period unless directed by a  doctor

Stop Use And Ask Doctor If



  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use or have rectal bleeding.

  • These could be signs of a serious condition.


Keep Out Of Reach Of Children



In case of over dose, get medical help or contact a Poison Control Center immediately.


Directions



  • take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. See choking warning.
  • dosage will vary according to diet, exercise, previous laxative use or severity of constipation
  • continued use for 1 to 3 days is normally required to provide full benefit

  • adults and children 12 years and over2 caplets, 1 to 4 times a day 
     children under 12 years  ask a doctor








Other Information



  • each caplet contains: calcium 135 mg
  • store at room temperature
  • protect contents from moisture

Inactive Ingredients



calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.


Principal Display Panel



NDC 36800-465-27
Topcare`     
COMPARE TO FIBERCON ACTIVE INGREDIENT
Fiber Laxative

CALCIUM POLYCARBOPHIL 625 mg

BULK-FORMING LAXATIVE

  • Gentle Enough for Everyday Use
  • Just as Effective as Fiber Powders

  • DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING 
    90 CAPLETS


* Please review the disclaimer below.