NDC 0904-7891 Dok Extra Strength Stool Softener

Docusate Sodium

NDC Product Code 0904-7891

NDC Code: 0904-7891

Proprietary Name: Dok Extra Strength Stool Softener 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 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.

Product Characteristics

Color(s):
ORANGE (C48331 - ORANGE)
Shape: CAPSULE (C48336)
Size(s):
20 MM
Imprint(s):
P20
Score: 1

NDC Code Structure

  • 0904 - Major Pharmaceuticals
    • 0904-7891 - Dok Extra Strength Stool Softener

NDC 0904-7891-59

Package Description: 100 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Dok Extra Strength Stool Softener with NDC 0904-7891 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Dok Extra Strength Stool Softener is docusate sodium. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Dok Extra Strength Stool Softener 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 250 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 08-27-2002 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2019 What is the End Marketing Date?
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.

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]

* Please review the disclaimer below.

Dok Extra Strength Stool Softener Product Label Images

Dok Extra Strength Stool Softener 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 250mg

Purpose

Stool softener

Uses

  • For the prevention of dry, hard stools
  • For relief of occasional constipation.
  • This product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do Not Use

  • If you are taking mineral oil, unless directed by a doctor
  • When abdominal pain, nausea, or vomiting are present
  • For more than 1 week, unless directed by a doctor

Ask A Doctor Before Use If

You notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use And Ask A Doctor If

  • You have rectal bleeding
  • You fail to have a bowel movement after use

If Pregnant Or Breastfeeding

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.

Directions

  • Adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctorchildren under 12 years of age: take as directed by a doctor

Other Information

  • Each softgel contains sodium 15mgstore at controlled room temperature 15o - 30o C (59o- 86o F)do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

Edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Product Labeling

MAJOR DOK™Docusate Sodium 250 mg Extra Strength Stool SoftenerFor use as a Stool Softener in treating & Avoiding ConstipationDistributed by:Major Pharmaceuticals31778 Enterprise DriveLivonia, MI 48150, USA

* Please review the disclaimer below.