Drugplain

DOCUSATE SODIUM, EXTRA STRENGTH 250 MG 250 mg/1

DOCUSATE SODIUM · CAPSULE, GELATIN COATED · Advanced Rx LLC

No Recall History
Plain English

Docusate sodium is an over-the-counter stool softener used to relieve constipation by helping to soften stool and make bowel movements easier. This extra strength formulation contains 250 mg of docusate sodium per gelatin capsule for oral use.

Key Facts

Brand Name
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG
Generic Name
DOCUSATE SODIUM
NDC Code (Product)
80513-101
Manufacturer
Advanced Rx LLC
Strength
250 mg/1
Dosage Form
CAPSULE, GELATIN COATED
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
05/25/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea1,575 reports
fatigue1,548 reports
dyspnoea1,358 reports
diarrhoea1,199 reports
constipation1,190 reports
vomiting1,168 reports
pain1,154 reports
off label use1,099 reports
death1,073 reports
pneumonia978 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

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 lasts 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.

Frequently Asked Questions

What is DOCUSATE SODIUM, EXTRA STRENGTH 250 MG used for?

Docusate sodium is an over-the-counter stool softener used to relieve constipation by helping to soften stool and make bowel movements easier. This extra strength formulation contains 250 mg of docusate sodium per gelatin capsule for oral use.

Is DOCUSATE SODIUM, EXTRA STRENGTH 250 MG a controlled substance?

DOCUSATE SODIUM, EXTRA STRENGTH 250 MG is not classified as a controlled substance by the DEA.

What is the generic name for DOCUSATE SODIUM, EXTRA STRENGTH 250 MG?

The generic name for DOCUSATE SODIUM, EXTRA STRENGTH 250 MG is DOCUSATE SODIUM. There are 12 other brand versions of DOCUSATE SODIUM.

What is the NDC code for DOCUSATE SODIUM, EXTRA STRENGTH 250 MG 250 mg/1?

The NDC (National Drug Code) for DOCUSATE SODIUM, EXTRA STRENGTH 250 MG 250 mg/1 is 80513-101, listed by Advanced Rx LLC.

Product NDC

80513-101

Package NDC

80513-101-01

Other Docusate Brands

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

Data from openFDA · Public domain (CC0 1.0)