Laxative and Stool Softener

Laxative and Stool Softener is an FDA-registered drug product whose active ingredient is DOCUSATE SODIUM, SENNOSIDES. It is labelled by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 49035-360, application 505G(a)(3), label effective 20260713. It is one of 7 FDA drug label records sharing the active ingredient DOCUSATE SODIUM, SENNOSIDES. 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, SENNOSIDES are most often described in connection with: relieves occasional, constipation irregularity, generally produces, bowel movement. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours

Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age or over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Warnings Do not use if you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week 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 continues over a period of 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 may indicate a serious condition. 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.

FDA lists 7 drug label records with DOCUSATE SODIUM, SENNOSIDES 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 Laxative and Stool Softener used for?
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours

Who makes Laxative and Stool Softener?
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) is the labeler of record for Laxative and Stool Softener. 7 FDA label records share the active ingredient DOCUSATE SODIUM, SENNOSIDES, 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 Laxative and Stool Softener 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 Laxative and Stool Softener 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, SENNOSIDES?
Yes. 7 FDA drug label records list DOCUSATE SODIUM, SENNOSIDES 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 Laxative and Stool Softener 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.