NDC 58354-117 Dyrax-q Tab

Bisacodyl, Docusate Sodium

NDC Product Code 58354-117

NDC CODE: 58354-117

Proprietary Name: Dyrax-q Tab What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Bisacodyl, Docusate Sodium 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Bisacodyl is used to treat constipation. It may also be used to clean out the intestines before a bowel examination/surgery. Bisacodyl is known as a stimulant laxative. It works by increasing the movement of the intestines, helping the stool to come out.
  • This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
7 MM
Score: 2

NDC Code Structure

  • 58354 - Cho-a Pharm.co.,ltd.
    • 58354-117 - Dyrax-q Tab

NDC Product Information

Dyrax-q Tab with NDC 58354-117 is a a human over the counter drug product labeled by Cho-a Pharm.co.,ltd.. The generic name of Dyrax-q Tab is bisacodyl, docusate sodium. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cho-a Pharm.co.,ltd.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

Dyrax-q Tab Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BISACODYL 5 mg/161mg
  • DOCUSATE SODIUM 16.75 mg/161mg

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Cho-a Pharm.co.,ltd.
Labeler Code: 58354
FDA Application Number: part334 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 10-25-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dyrax-q Tab Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Bisacodyl 5 mgDocusate Sodium 16.75 mg

Purpose

Laxative

Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control Center right away.

Uses

For temporary relief of occasional constipation and irregularity

Warnings

For external use onlyAsk a doctor before use if you havestomach pain, nausea or vomiting,

a sudden change in bowel habits that lasts more than 2 weeks
If Pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 15 years and older2 tablets at once per day (at bedtime)children 12 – 14 years1 1/3 tablet at once per day (at bedtime)children 8 – 11 years1 tablet at once per day (at bedtime)

Inactive Ingredients

Corn Starch, Colloidal Silicon Dioxide, Ethanol, Hydroxypropylcellulose, Lactose Hydrate, Magnesium Stearate, Sodium Lauryl Sulfate, OPADRY OY-C-7000A WHITE, ACRYL-EZE White, Food Yellow No.203, Food Blue No.1, Purified Water, Ursodesoxycholic Acid.

* Please review the disclaimer below.