NDC 68163-570 Unflavored Organic Natural Fiber
Psyllium Husk Powder Oral

Product Information

Product Code68163-570
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.
Unflavored Organic Natural Fiber
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.
Psyllium Husk
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 FormPowder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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.
Raritan Pharmaceuticals Inc
Labeler Code68163
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.
03-20-2019
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

Usage Information


Product Characteristics

Color(s)BROWN (C48332)

Product Packages

NDC 68163-570-85

Package Description: 595 g in 1 CANISTER

Product Details

Unflavored Organic Natural Fiber is a human over the counter drug product labeled by Raritan Pharmaceuticals Inc. The generic name of Unflavored Organic Natural Fiber is psyllium husk. The product's dosage form is powder and is administered via oral form.


What are Unflavored Organic Natural Fiber Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • RAW SUGAR (UNII: 8M707QY5GH)
  • GLYCERIN (UNII: PDC6A3C0OX)


* Please review the disclaimer below.

Patient Education

Psyllium

Psyllium is pronounced as (sil' i yum)

Why is psyllium medication prescribed?
Psyllium, a bulk-forming laxative, is used to treat constipation. It absorbs liquid in the intestines, swells, and forms a bulky stool, which is easy to pass.This medicat...
[Read More]
Black Psyllium

Black Psyllium is

...
[Read More]
Blond Psyllium

Blond Psyllium is

...
[Read More]

* Please review the disclaimer below.

Unflavored Organic Natural Fiber Labeling and Warnings

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.

Table of Contents



Active Ingredient



Psyllium husk 3.4g (1 rounded teaspoon = 7g)


Purpose



Bulk-forming laxative


Use



effective in treating occasional constipation and restoring regularity


Warnings



Allergy alert:This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.


Directions



Adults 12 Years and older (up to 3 times daily):

Put 1 rounded TEASPOON into an empty glass. Mix this product with at least 8 oz (a full glass) of water.

Stir briskly to mix the fiber into the water fully and drink promptly. Taking without enough water may cause choking. Do not take this product if you have difficulty following.

As bulk-forming fibers such as NuSyllium may affect how medicines work, take this product at least 2 hours before or after taking your medicine,

You can take NuSyllium at any time of the day.

Children under 12 years: Consult a doctor before use.

Stop using a NuSyllium and see a doctor if constipation lasts more than a week or if rectal bleeding occurs as these may be signs of a serious condition.

FIRST-TIME USERS

Start with one serving per day and then adjust your dose upwards as needed. Adding fiber to your diet may cause changes in your bowel habits or minor bloating.

These are normal reactions as your body adjusts to the increase fiber in your diet.


Other Information



Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from fiber such as NuSyllium may reduce the risk of heart disease by lowering cholesterol.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

ALLERGY ALERT: This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.


Questions Or Comments?



1-866-467-2748


Inactive Ingredients



Organic Brown Cane Sugar, Organic Vegetable Glycerin.


Principal Display Panel



NDC 68163-570-85

NuSyllium

Unflavored Organic Natural Fiber

100% Organic Certified Psyllium

Perfect Grind For Easy Mixing™

USDA ORGANIC

NO ARTIFICIAL INGREDIENTS

100% Natural Fiber Supplement

Fiber Laxative for Regularity

Made with 100% Organic Brown Cane Sugar

Folks are taking about the Benefits of NuSyllium Ultra Organic Natural Fiber!

  • You can use NuSyllium to feel less hungry between meals.
  • Maintain healthy blood sugar levels by using NuSyllium Ultra as part of your sugar free diet*. Talk to your doctor before use if you are taking medication to control your blood sugar levels.
  • Organic NuSyllium is a great choice for promoting and maintain digestive health. You can use NuSyllium Ultra for occasional constipation and to help promote and maintain regularity.
  • Did you know that one dose of NuSyllium Ultra contains 2 gm. of soluble fiber? You can use it for lowering cholesterol and promoting heart health*.
  • Talk to your doctor who will have good advice for you to use NuSyllium Ultra as part of your cholesterol –lowering program.
  • No Artificial Flavors, Peanut-free

    No Artificial Colors, Tree Nut-free

    GMO-free, Preservative-free

    Gluten-free, Zero Trans Fat

    Diary-free, No animal testing

    NET WT 21 OZ (595 g) 85 DOSES

    Fill controlled by weight, not volume

    Made in the U.S.A. with domestic and foreign components.

    Distributed by: Lifelab Health LLC

    6574 N.State Road #7 361

    Coconut Creek, FL 33073


* Please review the disclaimer below.