Colace

Colace is an FDA-registered drug product whose active ingredient is DOCUSATE SODIUM. It is labelled by Atlantis Consumer Healthcare, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 67618-111, application M007, label effective 20260824. 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.

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

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 Colace used for?
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Who makes Colace?
Atlantis Consumer Healthcare, Inc. is the labeler of record for Colace. 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 Colace 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 Colace 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 Colace 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.