FDA Label for Traulevium
View Indications, Usage & Precautions
Traulevium Product Label
The following document was submitted to the FDA by the labeler of this product Medical Technology Products, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (HPUS*)
Each tablet contains as active ingredients: Belladonna 4X 75 mg, Arnica Montana Radix 3X 40 mg, Aconitum Napellus 3X 30 mg, Chamomilla 3X 24 mg, Symphytum Officinale 8X 24 mg, Calendula Officinalis 2X 15 mg, Hamamelis Virginiana 2X 15 mg, Millefolium 3X 15 mg, Hepar Sulphuris Calcareum 8X 15 mg, Mercurius Solubilis 8X 15 mg, Hypericum Perforatum 3X 8 mg, Bellis Perennis 2X 6 mg, Echinacea Angustifolia 2X 6 mg, Echinacea Purpurea 2X 6 mg.
Otc - Purpose
Purpose** Relieves joint pain, back pain, muscular pain.
Indications & Usage
Uses** For the temporary relief of:
- Joint Pain
- Back Pain
- Muscular Pain
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
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. |
Other Safety Information
Other information
Tamper evident: Use this product only if imprinted shrink seal around the neck and cap is intact. Store tightly closed at room temperature. Protect from light and moisture.
**These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.
*The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
Inactive Ingredient
Inactive ingredients Lactose, Magnesium stearate.
Otc - Questions
Questions? Call 1.866.440.7703 or email [email protected]
Made in the USA. Manufactured exclusively for Medical Technology Products, Inc. by OHM pharma Inc.
Medical Technology Products, Inc.
Riviera Beach, FL 33407, USA.
Package Label.Principal Display Panel
NDC 70857-002-10
MTP
Traulevium™
PAIN RELIEF TABLETS
Homeopathic Medicine
Compare to Traumeel®. Traumeel is a brand name owned by Biologische Heilmittel Heel GmbH. Traulevium is not associated with the brand owner.
100 Chewable Tablets
* Please review the disclaimer below.