Stool Softener
Docusate Calcium
Rugby Laboratories, Inc.
Human Otc Drug
NDC 0536-1065Stool Softener also known as Docusate Calcium is a human otc drug labeled by 'Rugby Laboratories, Inc.'. National Drug Code (NDC) number for Stool Softener is 0536-1065. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Stool Softener drug includes Docusate Calcium - 240 mg/1 . The currest status of Stool Softener drug is Active.
Drug Information:
| Drug NDC: | 0536-1065 |
| 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 |
| 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 Calcium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rugby Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| 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 CALCIUM - 240 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: | 31 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Feb, 2024 |
| 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: | 22 Dec, 2025 |
| 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: | Rugby Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1245376
|
| 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: | 0305361065102
|
| UPC stands for Universal Product Code. |
| UNII: | 6K7YS503HC
|
| 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 |
|---|
| 0536-1065-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1065-01) | 31 Jan, 2015 | 23 Feb, 2024 | No |
| 0536-1065-05 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1065-05) | 31 Jan, 2015 | 23 Feb, 2024 | No |
| 0536-1065-10 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1065-10) | 31 Jan, 2015 | 23 Feb, 2024 | 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 laxative
Product Elements:
Stool softener docusate calcium docusate calcium docusate corn oil d&c red no. 33 fd&c red no. 40 gelatin glycerin water sorbitol fd&c blue no. 1 fd&c yellow no. 6 sorbitan p58;scu
Indications and Usage:
Uses for relief of occasional constipation. this product generally produces a bowel movement within 12 to72 hours.
Warnings:
Warnings do not use if you are currently 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 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 could be signs of a serious condition. you need to use a laxative for more than 1 week if pregnant or breastfeeding 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 if you are currently 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 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 could be signs of a serious condition. you need to use a laxative for more than 1 week if pregnant or breastfeeding 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 adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: 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 could be signs of a serious condition. you need to use a laxative for more than 1 week
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in surfax®** stool softener docusate calcium 240mg gentle relief of constipation take once a day softgels **this product is not manufactured or distributed by chattem, inc., distributor of surfak® this is a bulk package. dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the usp. distributed by: rugby laboratories 17177 n laurel park drive, suite 233 livonia, mi 48152 www.rugbylaboratories.com tamper evident: do not use if printed safety seal under cap is broken or missing
Product label rugby stool softener docusate calcium 240 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est