Unflavored Organic Natural Fiber
Psyllium Husk
Raritan Pharmaceuticals Inc
Human Otc Drug
NDC 68163-570Unflavored Organic Natural Fiber also known as Psyllium Husk is a human otc drug labeled by 'Raritan Pharmaceuticals Inc'. National Drug Code (NDC) number for Unflavored Organic Natural Fiber is 68163-570. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Unflavored Organic Natural Fiber drug includes Psyllium Husk - 3.4 g/7g . The currest status of Unflavored Organic Natural Fiber drug is Active.
Drug Information:
| Drug NDC: | 68163-570 |
| 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: | Unflavored Organic Natural Fiber |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | 20 Mar, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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 |
|---|
| 68163-570-85 | 595 g in 1 CANISTER (68163-570-85) | 20 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:
Unflavored organic natural fiber psyllium husk psyllium husk psyllium husk raw sugar glycerin
Indications and Usage:
Use for relief of occasional constipation (regularity)
Warnings:
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. allergy alert: this product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium. safety warning tamper-evident: do not use if printed seal under cap is torn or missing
Dosage and Administration:
Directions put one dose into an empty glass. mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. taking this product without enough liquid may cause choking. see choking warning. stir briskly and drink promptly. if mixture thickens, add more liquid. adults 12 years and older: 1 rounded teaspoon into an 8 oz of liquid at the first sign of irregularity. can be taken up to 3 times daily. generally produces effect in 12-72 hours. children under 12 years: consult a doctor before use. bulk-forming fibers like psyllium husk may affect how well other medicines work, if you are taking a prescription medicine by mouth, take this product at least 2 hours before or after the prescribed medicine. as your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. new users start with 1 serving per day; gradually increase to desired daily intake. you may initially experience changes in bowel habits or minor b
Read more...loating as your body adjusts to increased fiber intake. keep out of reach of children
Package Label Principal Display Panel:
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 âlowering 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, no animal testing nusyllium unflavored organic natural fiber
Further Questions:
Questions or comments? 1-866-467-2748