Drugplain

Stool Softener Laxative Extra Strength 250 mg/1

Docusate Sodium · CAPSULE, LIQUID FILLED · TOP CARE (Topco Associates LLC)

No Recall History
Plain English

Docusate sodium is an over-the-counter stool softener that helps make bowel movements easier by adding moisture to stools. It is commonly used to relieve constipation and is available as a 250 mg liquid-filled capsule taken by mouth.

Key Facts

Brand Name
Stool Softener Laxative Extra Strength
Generic Name
Docusate Sodium
NDC Code (Product)
36800-568
Manufacturer
TOP CARE (Topco Associates LLC)
Strength
250 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
11/29/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea1,577 reports
fatigue1,551 reports
dyspnoea1,359 reports
diarrhoea1,202 reports
constipation1,191 reports
vomiting1,168 reports
pain1,155 reports
off label use1,099 reports
death1,075 reports
pneumonia978 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves occasional constipation this product generally produces a bowel movement within 12 to 72 hours

Dosage & Administration

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

Warnings

Warnings 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 If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Stool Softener Laxative Extra Strength used for?

Docusate sodium is an over-the-counter stool softener that helps make bowel movements easier by adding moisture to stools. It is commonly used to relieve constipation and is available as a 250 mg liquid-filled capsule taken by mouth.

Is Stool Softener Laxative Extra Strength a controlled substance?

Stool Softener Laxative Extra Strength is not classified as a controlled substance by the DEA.

What is the generic name for Stool Softener Laxative Extra Strength?

The generic name for Stool Softener Laxative Extra Strength is Docusate Sodium. There are 12 other brand versions of Docusate Sodium.

What is the NDC code for Stool Softener Laxative Extra Strength 250 mg/1?

The NDC (National Drug Code) for Stool Softener Laxative Extra Strength 250 mg/1 is 36800-568, listed by TOP CARE (Topco Associates LLC).

Product NDC

36800-568

Package NDC

36800-568-10

Other Docusate Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)