Stool Softener with Laxative

Stool Softener with Laxative is an FDA-registered drug product whose active ingredient is DOCUSATE SODIUM AND SENNOSIDES. It is labelled by Geri-Care Pharmaceutical Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 57896-304, application 505G(a)(3), label effective 20231206. It is one of 6 FDA drug label records sharing the active ingredient DOCUSATE SODIUM AND 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 AND SENNOSIDES are most often described in connection with: relieves occasional, constipation irregularity, product generally, produces bowel, movement hours. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses relieves occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours

Directions Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses adults and children 12 years and over take 2-4 tablets daily children under 12 years of age ask a doctor

Warnings Do not use laxative products for longer than 1 week unless directed by a doctor 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. 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 6 drug label records with DOCUSATE SODIUM AND 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 Stool Softener with Laxative used for?
Uses relieves occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours

Who makes Stool Softener with Laxative?
Geri-Care Pharmaceutical Corp is the labeler of record for Stool Softener with Laxative. 6 FDA label records share the active ingredient DOCUSATE SODIUM AND 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 Stool Softener with Laxative 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 Stool Softener with Laxative 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 AND SENNOSIDES?
Yes. 6 FDA drug label records list DOCUSATE SODIUM AND 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 Stool Softener with Laxative 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.