DOCUSATE SODIUM, EXTRA STRENGTH 250 MG

DOCUSATE SODIUM, EXTRA STRENGTH 250 MG is an FDA-registered drug product whose active ingredient is DOCUSATE SODIUM. It is labelled by Advanced Rx LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 80513-101, application M007, label effective 20260706. It is one of 49 FDA drug label records sharing the active ingredient DOCUSATE SODIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DOCUSATE SODIUM are most often described in connection with: prevention dry, hard stools, relief occasional, product generally, produces bowel, movement within. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 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.

FDA lists 49 drug label records with DOCUSATE SODIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

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

Who makes DOCUSATE SODIUM, EXTRA STRENGTH 250 MG?
Advanced Rx LLC is the labeler of record for DOCUSATE SODIUM, EXTRA STRENGTH 250 MG. 49 FDA label records share the active ingredient DOCUSATE SODIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does DOCUSATE SODIUM, EXTRA STRENGTH 250 MG come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is DOCUSATE SODIUM, EXTRA STRENGTH 250 MG prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DOCUSATE SODIUM?
Yes. 49 FDA drug label records list DOCUSATE SODIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has DOCUSATE SODIUM, EXTRA STRENGTH 250 MG been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.