Docusate Calcium 240 Mg Sodium Free
Docusate Calcium
Avpak
Human Otc Drug
NDC 50268-266Docusate Calcium 240 Mg Sodium Free also known as Docusate Calcium is a human otc drug labeled by 'Avpak'. National Drug Code (NDC) number for Docusate Calcium 240 Mg Sodium Free is 50268-266. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Docusate Calcium 240 Mg Sodium Free drug includes Docusate Calcium - 240 mg/1 . The currest status of Docusate Calcium 240 Mg Sodium Free drug is Active.
Drug Information:
| Drug NDC: | 50268-266 |
| 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: | Docusate Calcium 240 Mg Sodium Free |
| 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: | Avpak |
| 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: | 17 May, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | AvPAK
|
| 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. |
| 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 |
|---|
| 50268-266-15 | 50 BLISTER PACK in 1 BOX (50268-266-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-266-11) | 17 May, 2017 | 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
Product Elements:
Docusate calcium 240 mg sodium free docusate calcium corn oil gelatin glycerin sorbitol water fd&c blue no. 1 fd&c red no. 40 docusate calcium docusate nv02
Indications and Usage:
Uses for the relief of occasional constipation. helps to prevent dry, hard stools. this product generally produces a bowel movement within 12 to 72 hours.
Warnings:
Warnings: do not use if you are currently taking mineral oil, unless directed by a doctor. when abdominal pain, nausea or vomiting are present. for longer than one week unless directed by a doctor.
Dosage and Administration:
Directions adults and children over 12 years of age take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor. children under 12 years of age do not use this product for children under 12 years of age, unless directed by a doctor.
Stop Use:
Stop use and ask a doctor if you have rectal bleeding. you fail to have a bowel movement after use.
Package Label Principal Display Panel:
Package/label principal display panel ndc 50268-266-15 avkare docusate calcium sodium-free stool softener 240 mg each 100 softgels usa av rev. 05/16 (p) manufactured for: avkare, inc. pulaski, tn 38478 1 2 3
Further Questions:
Questions or comments call 1-855-361-3993