Stool Softener
FDA Label NDC 54162-943

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Stool Softener (NDC 54162-943). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Ask A Doctor Before Use If You Have

  • stomach pain
  • nausea
  • vomitting
  • notice 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 laxative. These could be signs of serious condition.
  • you need to use a 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 accidental overdose, get medical help or contact a Poison Control Center right away

Directions

take only by mouth. Doses may be taken as a single daily does or in divided doses.

 Adults and children 12 years and over take 1-3 softgels daily          
 Children 2 to under 12 years of age take 1 softgel daily
 Children under 2 years ask a doctor

Other Information

  • each softgel contains: sodium 6 mg
  • store at 25°C (77°F); excursions premitted between 15-30°C (59-86°F)

Inactive Ingredients

D&C red #33, editable ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredients.

Questions Or Comments?

Call 1-800-736-3437

* Please review the disclaimer below.