Spirudio

Spirudio is an FDA-registered drug product whose active ingredient is SPIRUDIO. It is labelled by Progressive Health Research LLC taken by sublingual and marketed as a human otc drug product. Identifiers on file: NDC 87755-0001, label effective 20260608. It is one of 2 FDA drug label records sharing the active ingredient SPIRUDIO. 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 SPIRUDIO are most often described in connection with: three times, directions dissolve, stronger effects, best results. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Directions: Dissolve 1 tablet, three times daily under the tongue. For stronger effects, up to 2 tablets, three times daily may be taken. Use regularly for best results.

Directions: Dissolve 1 tablet, three times daily under the tongue. For stronger effects, take 2 tablets, up to three times daily. Use regularly for best results. Description Spirudio For Children is a gentle formula designed to support kids’ focus, calmness, and overall emotional balance. Safe and effective for children ages 5 and up, it works with the body to promote clarity and reduce everyday stress without harsh stimulants.

If pregnant or breastfeeding, ask a healthcare professional before use. If symptoms persist or worsen, discontinue use and consult a healthcare professional. Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. Consult a physician before use if you have a medical condition or are taking any medication. This product is not intended to diagnose, treat, cure, or prevent any disease.

FDA lists 2 drug label records with SPIRUDIO 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 Spirudio used for?
Directions: Dissolve 1 tablet, three times daily under the tongue. For stronger effects, up to 2 tablets, three times daily may be taken. Use regularly for best results.

Who makes Spirudio?
Progressive Health Research LLC is the labeler of record for Spirudio. 2 FDA label records share the active ingredient SPIRUDIO, 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 Spirudio come in?
administered by sublingual. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Spirudio 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 SPIRUDIO?
Yes. 2 FDA drug label records list SPIRUDIO 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 Spirudio 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.