Stool Softener Laxative
Docusate Sodium
Cardinal Health (leader) 70000
Human Otc Drug
NDC 70000-0091Stool Softener Laxative also known as Docusate Sodium is a human otc drug labeled by 'Cardinal Health (leader) 70000'. National Drug Code (NDC) number for Stool Softener Laxative is 70000-0091. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Stool Softener Laxative drug includes Docusate Sodium - 100 mg/1 . The currest status of Stool Softener Laxative drug is Active.
Drug Information:
| Drug NDC: | 70000-0091 |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health (leader) 70000 |
| 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 SODIUM - 100 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, 2021 |
| 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: | Cardinal Health (Leader) 70000
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1115005
|
| 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: | 0096295138528
|
| UPC stands for Universal Product Code. |
| UNII: | F05Q2T2JA0
|
| 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 |
|---|
| 70000-0091-1 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-1) | 31 Jan, 2021 | N/A | No |
| 70000-0091-2 | 250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-2) | 31 Jan, 2021 | N/A | No |
| 70000-0091-3 | 750 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-3) | 31 Jan, 2021 | 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 laxative
Product Elements:
Stool softener laxative docusate sodium docusate sodium docusate d&c red no. 33 fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified propylene glycol water sorbitan sorbitol titanium dioxide ammonia isopropyl alcohol lecithin, soybean mineral oil butyl alcohol alcohol potassium hydroxide pc18
Indications and Usage:
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Warnings:
Warnings do not use if you are presently taking mineral oil, unless told to do so by a doctor. ask a doctor before use if you have stomach pain nausea vomiting 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 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 (1-800-222-1222) right away.
Do Not Use:
Warnings do not use if you are presently taking mineral oil, unless told to do so by a doctor. ask a doctor before use if you have stomach pain nausea vomiting 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 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 (1-800-222-1222) right away.
Dosage and Administration:
Directions take only by mouth. doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years 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 colace® regular strength active ingredient stool softener docusate sodium 100 mg stool softener laxative gentle dependable stimulant-free softgels this product is not manufactured or distributed by avrio healthl.p., distributor of colace® regular strength. tamper evident: do not use if printed safety seal under cap is broken or missing. distributed by cardinal health dublin, ohio 43017 www.myleader.com
Product label leader stool softener laxative docusate sodium 100 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est