Ultra Organic Fiber Sugar Free
Psyllium Husk
Raritan Pharmaceuticals Inc
Human Otc Drug
NDC 68163-575Ultra Organic Fiber Sugar Free also known as Psyllium Husk is a human otc drug labeled by 'Raritan Pharmaceuticals Inc'. National Drug Code (NDC) number for Ultra Organic Fiber Sugar Free is 68163-575. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Ultra Organic Fiber Sugar Free drug includes Psyllium Husk - 3.4 g/7g . The currest status of Ultra Organic Fiber Sugar Free drug is Active.
Drug Information:
| Drug NDC: | 68163-575 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ultra Organic Fiber Sugar Free |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Ultra Organic Fiber |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Sugar Free |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Psyllium Husk |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Raritan Pharmaceuticals Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PSYLLIUM HUSK - 3.4 g/7g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 18 Mar, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Raritan Pharmaceuticals Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 824586
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 0SHO53407G
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68163-575-42 | 300 g in 1 CANISTER (68163-575-42) | 18 Mar, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose bulk-forming laxative
Product Elements:
Ultra organic fiber sugar free psyllium husk psyllium husk psyllium husk anhydrous citric acid stevia rebaudiuna leaf glycerin orange flavor
Indications and Usage:
Use effective in treating occasional constipation and restoring regularity
Warnings:
Warnings allergy alert: this product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium . safety warning do not use if printed seal under cap is torn or missing
Dosage and Administration:
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 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
Read more... in your diet. keep out of reach of children
Package Label Principal Display Panel:
Principal display panel ndc 68163-575-42 nusyllium ultra sugar free organic fiber 7 grams of fiber per teaspoon dose perfect grind⢠for easy mixing ⢠fiber laxative for regularity ⢠natural orange flavor no artificial ingredients 42 doses weight 10.7 oz (300 grams) fill controlled by weight, not volume *compared to leading nusyllium product folks are taking about the benefits of nusyllium ultra organic natural fiber! ⢠you can use nusyllium ultra 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 5 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 âlowering program. no artificial flavors, peanut-free no artificial colors, tea nut-free gmo-free, preservative-free gluten-free, zero trans fat diary-free, no animal testing 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 ultra organic sugar free organic fiber
Further Questions:
Questions or comments? 1-866-467-2748