Docusate Sodium - Stool Softener Laxative

Docusate Sodium - Stool Softener Laxative is an FDA-registered drug product whose active ingredient is DOCUSATE SODIUM. It is labelled by Cardinal Health 107, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55154-3369, application M007, label effective 20260728. 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: relief occasional, constipation irregularity, generally produces, bowel movement, within hours. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • for relief of occasional constipation (irregularity) • This generally produces a bowel movement within 12 to 72 hours.

Directions • take softgels with a full glass (8 oz) of water adults and children 12 years of age and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years of age take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor

Warnings Ask a doctor before use if you have • abdominal pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days Ask a doctor or pharmacist before use if you are presently taking mineral oil Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These can 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 care professional before use. Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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 - Stool Softener Laxative used for?
Uses • for relief of occasional constipation (irregularity) • This generally produces a bowel movement within 12 to 72 hours.

Who makes Docusate Sodium - Stool Softener Laxative?
Cardinal Health 107, LLC is the labeler of record for Docusate Sodium - Stool Softener Laxative. 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 - Stool Softener 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 Docusate Sodium - Stool Softener 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?
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 - Stool Softener 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.