Stool Softener
FDA Label NDC 51013-401

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Stool Softener (NDC 51013-401). 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, do not use, ask a doctor before use if you have, stop use and ask a doctor if, 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 250 mg

Purpose

Stool softener laxative

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

Do Not Use

if you are presently taking mineral oil, unless directed by a doctor.

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

  • 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

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

Other Information

  • each softgel contains:sodium 15 mg
  • store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

STOOL SOFTENER

DOCUSATE SODIUM 250mg 100 SOFTGELS

Compare to the active ingredient in COLACE®

NDC 51013-401-24

Bottle Label (Mb17 00)

Bottle Label (Mb17 00)

* Please review the disclaimer below.