Careone
Psyllium Husk
Foodhold Usa
Human Otc Drug
NDC 41520-907Careone also known as Psyllium Husk is a human otc drug labeled by 'Foodhold Usa'. National Drug Code (NDC) number for Careone is 41520-907. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Careone drug includes Psyllium Husk - .52 g/1 . The currest status of Careone drug is Active.
Drug Information:
| Drug NDC: | 41520-907 |
| 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: | Careone |
| 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: | Foodhold Usa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| 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 - .52 g/1
|
| 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: | 16 Apr, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| 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: | FOODHOLD USA
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 581417
|
| 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 |
|---|
| 41520-907-60 | 160 CAPSULE in 1 BOTTLE (41520-907-60) | 16 Apr, 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 fiber laxative
Product Elements:
Careone psyllium husk psyllium husk psyllium husk caramel gelatin, unspecified polysorbate 80 rp119
Indications and Usage:
Uses ⪠effective in treating occasional constipation and restoring 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 allergic reaction in people sensitive to inhaled or ingested psyllium. ask a doctor before use if you have ⪠a sudden change in bowel habits persisting for 2 weeks ⪠abdominal pain, nausea or vomiting stop use and ask a doctor if ⪠constipation lasts more than 7 days ⪠rectal bleeding occurs 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 at 1-800-222-1222.
Dosage and Administration:
Directions ⪠take this product 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. ⪠adults 12 years and older: 5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. can be taken up to 3 times daily. generally produces effect in 12-72 hours. ⪠children 12 years and under: ask a doctor ⪠laxatives, including bulk fibers, may affect how well other medicines work. if you are taking a prescription medication by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. ⪠as your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
Package Label Principal Display Panel:
Principal display panel - 160 capsules label ndc 41520-907-60 compare to metamucil ® capsules â¡ fiber capsules psyllium husk fiber supplement 100% natural psyllium husk bulk forming laxative dietary fiber supplement 160 capsules our pharmacists recommend **these staements have not been evaluated by food and drug adminstration, this product is not inteded to diagnose, treat, cure or prevent any disease gluten free (may contain trace amount less than 20 ppm). if you have specific dietary needs, you should dietary needs; you should consult your doctor before consuming this product) distributed by foodhold u.s.a. llc landover, md 20785 1-877-846-9949 2018 s&s brands, llc quality guaranteed or your money back. *this product is not manufactured or distributed by procter & gamble, the distributor of metamucil ® 3 in1 multihealth fiber!â¢. careone fiber capsule 160 counts
Further Questions:
Questions or comments? 1-866-467-2748