Topcare Stool Softener

Topcare Stool Softener is an FDA-registered drug product whose active ingredient is DOCUSATE SODIUM. It is labelled by TopCo Associates, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 76162-006, application M007, label effective 20210219. 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: 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.

Use(s) relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over: Take 1-3 softgels daily Children 2 to under 12 years of age : Take 1 softgel daily Children under 2 years: Ask a doctor

Warnings Do not use if you are presently taking mineral oil, unless told to do so 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 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 could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 Topcare Stool Softener used for?
Use(s) relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Who makes Topcare Stool Softener?
TopCo Associates, LLC is the labeler of record for Topcare Stool Softener. 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 Topcare 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 Topcare 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?
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 Topcare 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.