Docusate Sodium
FDA Label NDC 55910-223

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. for the product Docusate Sodium (NDC 55910-223). 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 other, active ingredient (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg 

Purpose

Stool Softner 

Uses

  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Warnings

Do Not Use

  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask A Doctor Before Use If You Have

  • stomach pain
  •  nausea
  • vomittiong
  • a sudden change in bowel habits that lasts more than 2 weeks

Stop Use And Ask A Doctor If

  • you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition.
  • yo need to use a stool softener laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Directions

Take only by mouth. Doses may be taken as a single daily dose 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 of age: ask a doctor

Other Information

  • Store at 25°C  (77°F), excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed.

Inactive Ingredients

gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions Or Comments?

1-888-309-9030

Principal Display Panel

DGTM Health

Compare to the active ingredient of Colace®*

STOOL SOFTENER CLEAR

DOCUSATE SODIUM 100 mg

Relieves constipation

Gentle Relief

Stimulant-Free
Dye-Free

100 Softgels

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace.

* Please review the disclaimer below.