NDC 68163-575 Ultra Organic Fiber Sugar Free

Psyllium Husk

NDC Product Code 68163-575

NDC 68163-575-42

Package Description: 300 g in 1 CANISTER

NDC Product Information

Ultra Organic Fiber Sugar Free with NDC 68163-575 is a a human over the counter drug product labeled by Raritan Pharmaceuticals Inc. The generic name of Ultra Organic Fiber Sugar Free is psyllium husk. The product's dosage form is powder and is administered via oral form.

Labeler Name: Raritan Pharmaceuticals Inc

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.

Ultra Organic Fiber Sugar Free 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.

  • PSYLLIUM HUSK 3.4 g/7g

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Raritan Pharmaceuticals Inc
Labeler Code: 68163
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: 03-18-2019 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.

Ultra Organic Fiber Sugar Free Product Label Images

Ultra Organic Fiber Sugar Free 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

Psyllium husk 3.4g (per each 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 Ultra may affect how medicines work, take this product at least 2 hours before or after taking your medicine,You can take NuSyllium Ultra 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 USERSStart 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.

Keep Out Of Reach Of Children

[Enter Keep Out of Reach of Children here]

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.

Inactive Ingredients

Natural Citric Acid, Natural Flavors, Natural Stevia Extract, Organic Glycerin.

* Please review the disclaimer below.

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