Traulevium

Traulevium is an FDA-registered drug product whose active ingredient is BELLADONNA, ARNICA MONTANA RADIX, ACONITUM NAPELLUS, CHAMOMILLA, SYMPHYTUM OFFICINALE, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA.. It is labelled by Medical Technology Products, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 70857-002, label effective 20211229. 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 BELLADONNA, ARNICA MONTANA RADIX, ACONITUM NAPELLUS, CHAMOMILLA, SYMPHYTUM OFFICINALE, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA. are most often described in connection with: temporary relief, joint pain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses** For the temporary relief of: Joint Pain Back Pain Muscular Pain

Directions Allow tablets to dissolve completely in the mouth, do not swallow. Standard Dosage Adults and children 12 years & older 3 tablets per day, taking 1 tablet every 4 to 6 hours. Children 4 to 11 years 2 tablets per day, taking 1 tablet every 6 to 8 hours. Children under 4 years Consult your healthcare provider. Initial Dosage Adults and children 12 years & older 1 tablet every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours. Children 4 to 11 years 1 tablet every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 8 tablets in 24 hours. Children under 4 years Consult your healthcare provider.

Warnings If symptoms worsen or persist for more than a week, a healthcare provider should be consulted. Do not use if known sensitivity to Traulevium or any of its ingredients exists. Keep out of the reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding , ask a healthcare provider before use. Keep out of reach of children.

What is Traulevium used for?
Uses** For the temporary relief of: Joint Pain Back Pain Muscular Pain

Who makes Traulevium?
Medical Technology Products, Inc. is the labeler of record for Traulevium.

What form does Traulevium 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 Traulevium 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.

Has Traulevium 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.