Traulevium Tablet, Chewable
FDA Label NDC 70857-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medical Technology Products, Inc. for the product Traulevium (NDC 70857-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 & older3 tablets per day, taking 1 tablet every 4 to 6 hours.
Children 4 to 11 years2 tablets per day, taking 1 tablet every 6 to 8 hours.
Children under 4 yearsConsult 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 years1 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 yearsConsult 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.

www.traulevium.com

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.