NDC 16103-399 Docusate Sodium

Docusate Sodium 100mg

NDC Product Code 16103-399

NDC CODE: 16103-399

Proprietary Name: Docusate Sodium 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: Docusate Sodium 100mg 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.

  • 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):
RED (C48326 - TWO-TONED- WHITE AND CLEAR RED)
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
SCU2
Score: 1

NDC Code Structure

NDC 16103-399-08

Package Description: 100 CAPSULE in 1 BOTTLE

NDC 16103-399-11

Package Description: 1000 CAPSULE in 1 BOTTLE

NDC Product Information

Docusate Sodium with NDC 16103-399 is a a human over the counter drug product labeled by Pharbest Pharmaceuticals, Inc.. The generic name of Docusate Sodium is docusate sodium 100mg. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Pharbest Pharmaceuticals, Inc.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Docusate Sodium 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.

  • DOCUSATE SODIUM 100 mg/1

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.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.

Product Labeler Information

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

Labeler Name: Pharbest Pharmaceuticals, Inc.
Labeler Code: 16103
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: 03-01-2016 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: 12-31-2021 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.

Information for Patients

Stool Softeners

Stool Softeners is

Why is stool softeners medication prescribed?
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, hemorrhoid...
[Read More]
Stool Softeners

Stool Softeners is
Why is stool softeners medication prescribed?
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, hemorrhoid...
[Read More]

* Please review the disclaimer below.

Docusate Sodium 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 Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • Relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

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 painnauseavomitingnoticed 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 bowel movement after use of a laxative. These could be signs of a serious condition.you need to use a stool softener 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 right away. (1-800-222-1222)

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 dailychildren 2 to under 12 years of agetake 1 softgel dailychildren under 2 yearsask a doctor

Other Information

  • Tamper Evident: Do not use if safety seal under cap is broken or missingeach softgel contains: sodium 6 mgVERY LOW SODIUMstore at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF).keep tightly closed.

Inactive Ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

* Please review the disclaimer below.