Sanguinaria canadensis

Sanguinaria canadensis is an FDA-registered drug product whose active ingredient is SANGUINARIA CANADENSIS ROOT. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-4550, label effective 20231114. It is one of 8 FDA drug label records sharing the active ingredient SANGUINARIA CANADENSIS ROOT. 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 SANGUINARIA CANADENSIS ROOT are most often described in connection with: hot flashes, periodic headache. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Hot flashes with periodic headache*

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

FDA lists 8 drug label records with SANGUINARIA CANADENSIS ROOT 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.

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Sanguinaria canadensis used for?
Hot flashes with periodic headache*

Who makes Sanguinaria canadensis?
Boiron is the labeler of record for Sanguinaria canadensis. 8 FDA label records share the active ingredient SANGUINARIA CANADENSIS ROOT, 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 Sanguinaria canadensis 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 Sanguinaria canadensis 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 SANGUINARIA CANADENSIS ROOT?
Yes. 8 FDA drug label records list SANGUINARIA CANADENSIS ROOT 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 Sanguinaria canadensis been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.