NDC 0224-2001 Konsyl Care Total Fiber

Psyllium Husk

NDC Product Code 0224-2001

NDC CODE: 0224-2001

Proprietary Name: Konsyl Care Total 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: Psyllium Husk 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat constipation. It increases the bulk in your stool, an effect that helps to cause movement of the intestines. It also works by increasing the amount of water in the stool, making the stool softer and easier to pass. Psyllium, one type of bulk-forming laxative, has also been used along with a proper diet to treat high cholesterol.

NDC Code Structure

  • 0224 - Konsyl Pharmaceuticals, Inc.

NDC 0224-2001-91

Package Description: 340 g in 1 BAG

NDC Product Information

Konsyl Care Total Fiber with NDC 0224-2001 is a a human over the counter drug product labeled by Konsyl Pharmaceuticals, Inc.. The generic name of Konsyl Care Total Fiber is psyllium husk. The product's dosage form is powder and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1095534 and 1095536.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Konsyl Care Total 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.


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: Konsyl Pharmaceuticals, Inc.
Labeler Code: 0224
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: 08-01-2019 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: 12-31-2021 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 - NO 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".

* Please review the disclaimer below.

Konsyl Care Total Fiber Product Label Images

Konsyl Care Total 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 Teaspoon)

Psyllium Hydrophilic Mucilloid 6g

Purpose

Bulk-forming laxative

Use

For relief of occasional constipation and aid in regularity. This prouct generally produces bowel movements within 12-72 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.

Do Not Use

  • When abdominal pain, nausea or vomiting are present unless directed by a doctorif constipation laste more than seven daysif you have difficulty swallowing

Ask A Doctor Before Use If You Have

Noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use And Ask A Doctor If

  • You experience rectal bleeding or fail to have a bowel movement, as these may be signs of a serious condition

Keep Out Of Reach Of Children.

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

Directions

Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning. adults and children 12 years and olderone teaspon 1 to 3 times dailychildren 6 to under 12 years of age 1/2 teaspon 1 to 3 times dailychildren under 6 years of age consult a doctor

Other Information

  • Each 6g dose contains
  • Potassium 50mg
  • Laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicinestamper-evident bag sealed for your protectiondo not use if seal of bag is broken or missingdo not discard Konsyl into any plumbing systemstore below 86° F (30° C)keep bag tightly closed to protect from excessive moisture

Inactive Ingredients

Water

* Please review the disclaimer below.