Stool Softener Laxative
Docusate Sodium And Sennosides
Winco Foods, Llc
Human Otc Drug
NDC 67091-373Stool Softener Laxative also known as Docusate Sodium And Sennosides is a human otc drug labeled by 'Winco Foods, Llc'. National Drug Code (NDC) number for Stool Softener Laxative is 67091-373. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Stool Softener Laxative drug includes Docusate Sodium - 50 mg/1 Sennosides - 8.6 mg/1 . The currest status of Stool Softener Laxative drug is Active.
Drug Information:
| Drug NDC: | 67091-373 |
| 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: | Stool Softener Laxative |
| 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: | Docusate Sodium And Sennosides |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Winco Foods, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | DOCUSATE SODIUM - 50 mg/1
SENNOSIDES - 8.6 mg/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: | 30 Oct, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | WinCo Foods, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998740
|
| 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: | 0070552230613
|
| UPC stands for Universal Product Code. |
| UNII: | F05Q2T2JA0
3FYP5M0IJX
|
| 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 |
|---|
| 67091-373-60 | 60 TABLET in 1 BOTTLE, PLASTIC (67091-373-60) | 30 Oct, 2020 | 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 stool softener stimulant laxative
Product Elements:
Stool softener laxative docusate sodium and sennosides docusate sodium docusate sennosides sennosides croscarmellose sodium dibasic calcium phosphate dihydrate fd&c red no. 40 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified silicon dioxide talc titanium dioxide aluminum oxide fd&c blue no. 2 psd21
Indications and Usage:
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to12 hours
Warnings:
Warnings do not use laxative products for longer than 1 week unless directed by a doctor if you are now taking mineral oil, unless directed by a doctor ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. these may indicate a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use laxative products for longer than 1 week unless directed by a doctor if you are now taking mineral oil, unless directed by a doctor ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. these may indicate a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions take only by mouth. doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and older take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor
Stop Use:
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. these may indicate a serious condition.
Package Label Principal Display Panel:
Principal display panel **compare to the active ingredients in colace®2-in-1 stool softener & stimulant laxative docusate sodium 50 mg/ stool softener sennosides 8.6 mg/ stimulant laxative dependable relief in 6-12 hours tablets ** this product is not manufactured or distributed by avrio health l.p., distributor of colace® 2-in-1. tamper evident: do not use if printed safety seal under cap is broken or missing. distributed by: winco foods, llc, boise, id 83704
Product label winco foods stool softener laxative docusate sodium 50 mg, sennosides 8.6 mg
Further Questions:
Questions or comments? call 1-800-824-1706 monday-friday 9am-4pm mst