NDC 63868-878 Stool Softener Plus Laxative

Docusate Sodium,Sennosides Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
63868-878
Proprietary Name:
Stool Softener Plus Laxative
Non-Proprietary Name: [1]
Docusate Sodium, Sennosides
Substance Name: [2]
Docusate Sodium; Sennosides
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Quality Choice (chain Drug Marketing Association)
    Labeler Code:
    63868
    FDA Application Number: [6]
    part334
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    10-30-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331)
    Shape:
    ROUND (C48348)
    Size(s):
    10 MM
    Imprint(s):
    PSD22
    Score:
    1

    Product Packages

    NDC Code 63868-878-60

    Package Description: 1 BOTTLE in 1 BOX / 60 TABLET in 1 BOTTLE

    Product Details

    What is NDC 63868-878?

    The NDC code 63868-878 is assigned by the FDA to the product Stool Softener Plus Laxative which is a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Stool Softener Plus Laxative is docusate sodium, sennosides. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 63868-878-60 1 bottle in 1 box / 60 tablet in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Stool Softener Plus Laxative?

    Take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

    What are Stool Softener Plus Laxative Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • DOCUSATE SODIUM 50 mg/1 - All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt.
    • SENNOSIDES 8.6 mg/1 - Medications derived from SENNA EXTRACT that are used to treat CONSTIPATION.

    Which are Stool Softener Plus Laxative UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Stool Softener Plus Laxative Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Stool Softener Plus Laxative?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 998740 - sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet
    • RxCUI: 998740 - docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet
    • RxCUI: 998740 - DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet

    * Please review the disclaimer below.

    Patient Education

    Senna


    Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
    [Learn More]


    Stool Softeners


    Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.
    [Learn More]


    Senna


    What is it? Senna is the fruit (pod) or leaf of the plant Senna alexandrina. It is approved in the US as a laxative for short-term treatment of constipation.

    Senna contains many chemicals called sennosides. Sennosides irritate the lining of the bowel, which causes a laxative effect.

    Senna is an FDA-approved over-the-counter (OTC) laxative. It is used to treat constipation and also to clear the bowel before procedures such as colonoscopy. People also use senna for irritable bowel syndrome (IBS), hemorrhoids, weight loss, and many other conditions, but there is no good scientific evidence to support these uses.


    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - 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.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".