FDA.reportPublic FDA data

Traulevium PAIN RELIEF TABLETS

Manufacturer
Medical Technology Products, Inc.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:22

Label at a glance#

ProductTraulevium
Active ingredientATROPA BELLADONNA, ARNICA MONTANA, ACONITUM NAPELLUS, MATRICARIA RECUTITA, COMFREY ROOT, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, CALCIUM SULFIDE, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


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 SECTION

Purpose** Relieves joint pain, back pain, muscular pain.

INDICATIONS & USAGE SECTION

Uses** For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain

WARNINGS SECTION

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 SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Inactive ingredients Lactose, Magnesium stearate.

OTC - QUESTIONS SECTION

Questions? Call 1.866.440.7703 or email info@traulevium.com

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

100 tablets bottle label100 tablets bottle label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70857-002-10Traulevium100 in 1 BOTTLETABLET, CHEWABLE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70857-002TRAULEVIUM (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.) TABLET, CHEWABLE [MEDICAL TECHNOLOGY PRODUCTS, INC.]4Current NDC, Legacy NDC, 1 package rows20211230_6123d145-4edf-4ecd-8b30-196e52273127.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70857-00270857-002-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
ARNICA MONTANAO80TY208ZWACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
COMFREY ROOTM9VVZ08EKQACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
BELLIS PERENNIS2HU33I03UYACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrauleviumBELLADONNA, 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.Medical Technology Products, Inc.6123d145-4edf-4ecd-8b30-196e522731272021-12-29WarningsExact identifier
ndc (package): 70857-002-10
ndc (product): 70857-002
ndc11 (package): 70857000210
spl id: d44bff7e-57cc-a6fa-e053-2a95a90a4e04
spl set id: 6123d145-4edf-4ecd-8b30-196e52273127

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.