Dg Health Sugar Free
Fiber Therapy Psyllium Husk
Dolgencorp, Llc
Human Otc Drug
NDC 55910-551Dg Health Sugar Free also known as Fiber Therapy Psyllium Husk is a human otc drug labeled by 'Dolgencorp, Llc'. National Drug Code (NDC) number for Dg Health Sugar Free is 55910-551. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Dg Health Sugar Free drug includes Psyllium Husk - 3.4 g/5.8g . The currest status of Dg Health Sugar Free drug is Active.
Drug Information:
| Drug NDC: | 55910-551 |
| 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: | Dg Health Sugar Free |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Dg Health |
| 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: | Fiber Therapy Psyllium Husk |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dolgencorp, Llc |
| 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/5.8g
|
| 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 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | DOLGENCORP, LLC
|
| 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. |
| UPC: | 0368163515411
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 55910-551-48 | 283 g in 1 BOTTLE (55910-551-48) | 16 May, 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 therapy for regularity
Product Elements:
Dg health sugar free fiber therapy psyllium husk psyllium husk psyllium husk aspartame anhydrous citric acid fd&c yellow no. 6 maltodextrin silicon dioxide light yellowish
Indications and Usage:
Uses: ⢠for relief 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 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: 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 and stir. adults 12 years & older: 1 rounded teaspoon in 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. 6-11 yrs : ½ adult dose in 8 ounces of liquid, up to 3 times daily under 6 yrs: consult a doctor 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 2 hours 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 dose per day; gradually increased to 3doses per day as necessary.
Stop Use:
Stop use and ask a doctor if ⢠constipation lasts more than 7 days ⢠rectal bleeding occurs these may be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel ndc 55910-551-48 dg⢠health compare to the active ingredient in metamucil ® multihealth fiber* sugar free fiber therapy 100% natural psyllium husk daily fiber supplement therapy for regularity ⢠orange smooth fiber powder ⢠helps lower cholesterol to promotes heart health** ⢠promotes digestives health â ⢠helps maintain healthy blood sugar levels as part of your diet â ⢠gluten free orange flavor naturally and artificially flavored 48 teaspoon doses k pareve net wt 10 oz (283 g) fill controlled by weight, not volume **see fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels. â these statement have not been evaluated by the food and drug administration. this product is not intended to diagnose, treat, cure or prevent any disease. do not use if printed inner seal is broken or missing *this product is not manufactured or distributed by procter & gamble, the distributor of metamucil ® . distributed by: dolgencorp, llc 100 mission ridge goodlettsville, tn 37072 dg health sugar free fiber therapy