NDC 61919-888 Docusate Sodium

Product Information

Product Code61919-888
Proprietary Name 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.
Docusate Sodium
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Direct Rx
Labeler Code61919
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-01-2015
Listing Expiration Date 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.
12-31-2017
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)RED (C48326 - REDDISH)
ShapeCAPSULE (C48336)
Size(s)12 MM
Imprint(s)SCU1
Score1

Product Packages

NDC 61919-888-30

Package Description: 30 TABLET in 1 BOTTLE

NDC 61919-888-60

Package Description: 60 TABLET in 1 BOTTLE

NDC 61919-888-71

Package Description: 100 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Docusate Sodium is product labeled by Direct Rx. The product's dosage form is and is administered via form.


What are Docusate Sodium Active Ingredients?

The following is the list of active ingredients in this product. 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 (UNII: F05Q2T2JA0)
  • DOCUSATE (UNII: M7P27195AG) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? 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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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 GLYCOL 400 (UNII: B697894SGQ)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)


* Please review the disclaimer below.

Docusate Sodium Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient Section



Docusate sodium 100 mg


Otc - Purpose Section



Stool softener


Indications & Usage Section




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


Otc - Do Not Use Section



Do not use if you are presently taking mineral oil, unless told to do so by a doctor


Otc - Ask Doctor Section




stomach pain  
nausea  
vomiting  
noticed a sudden change in bowel habits that lasts over 2 weeks


Otc - Stop Use Section




you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.  
you need to use a laxative for more than 1 week


Otc - Pregnancy Or Breast Feeding Section



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children Section



In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration Section



doses may be taken as a single daily dose or in divided doses


Other Safety Information



each softgel contains: sodium 5 mg VERY LOW SODIUM  
store at 15°-30°C (59°-86°F)  
keep tightly closed

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.


Inactive Ingredient Section



FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special


Other



Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

R0 07/2011
015021CPR


Package Label.Principal Display Panel




* Please review the disclaimer below.