Passiflora incarnata

Passiflora incarnata is an FDA-registered drug product whose active ingredient is PASSIFLORA INCARNATA FLOWERING TOP. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-3936, label effective 20230720. It is one of 5 FDA drug label records sharing the active ingredient PASSIFLORA INCARNATA FLOWERING TOP. 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 PASSIFLORA INCARNATA FLOWERING TOP are most often described in connection with: occasional sleeplessness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Occasional sleeplessness*

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 5 drug label records with PASSIFLORA INCARNATA FLOWERING TOP 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.

1 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 Passiflora incarnata used for?
Occasional sleeplessness*

Who makes Passiflora incarnata?
Boiron is the labeler of record for Passiflora incarnata. 5 FDA label records share the active ingredient PASSIFLORA INCARNATA FLOWERING TOP, 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 Passiflora incarnata 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 Passiflora incarnata 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 PASSIFLORA INCARNATA FLOWERING TOP?
Yes. 5 FDA drug label records list PASSIFLORA INCARNATA FLOWERING TOP 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 Passiflora incarnata been recalled?
1 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.