NDC 61919-888 Docusate Sodium

NDC Product Code 61919-888

NDC CODE: 61919-888

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: 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.

NDC Code Structure

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.

NDC Product Information

Docusate Sodium with NDC 61919-888 is a product labeled by Direct Rx. The generic name of Docusate Sodium is . The product's dosage form is and is administered via form.

Labeler Name: Direct Rx

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

Product Labeler Information

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

Labeler Name: Direct Rx
Labeler Code: 61919
Start Marketing Date: 01-01-2015 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Docusate Sodium Product Label Images

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

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 closedYou 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 PHARMACEUTICALSHUNTSVILLE, AL 35811R0 07/2011015021CPR

* Please review the disclaimer below.