NDC 55315-244 Stool Softener

NDC Product Code 55315-244

NDC CODE: 55315-244

Proprietary Name: 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: 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):
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
P51;S77;SCU1
Score: 1

NDC Code Structure

NDC 55315-244-25

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

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

NDC Product Information

Stool Softener with NDC 55315-244 is a product labeled by Freds Inc. The generic name of Stool Softener is . The product's dosage form is and is administered via form.

Labeler Name: Freds Inc

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)
  • SORBITAN (UNII: 6O92ICV9RU)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Labeler Information

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

Labeler Name: Freds Inc
Labeler Code: 55315
Start Marketing Date: 04-30-2015 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: 12-31-2020 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: 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.

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.

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 100 mg

Purpose

Stool softener laxative

Uses

  • For temporary relief of occasional constipation and irregularity
  • This product generally produces bowel movement in 12 to 72 hours

Ask A Doctor Before Use If You Have

  • Stomach pain
  • Nausea
  • Vomiting
  • A sudden change in bowel habits that lasts more than 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

Presently taking mineral oil.

Stop Use And Ask A Doctor If

  • You have rectal bleeding or no bowel movement after using a laxative. These could be sign of a serious condition.
  • You need to use a laxative for more than 1 week

If Pregnant Or Breast-Feeding,

Ask a health care 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

  • Take with a glass of water adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor

Other Information

  • Each softgel contains: sodium 7mg
  • Store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, medium-chain triglycerides*,polyethylene glycol, propylene glycol*, purified water sorbitan,sorbitol*contains one or more of these ingredients

Product Label

Freds Stool Softener

* Please review the disclaimer below.