FDA.reportPublic FDA data

Traumeel Rx Tablet

Manufacturer
MediNatura Inc | Biologische Heilmittel Heel
Effective date
2021-10-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:31:59

Label at a glance#

ProductTraumeel Rx
Active ingredientATROPA BELLADONNA, ECHINACEA, UNSPECIFIED, ACHILLEA MILLEFOLIUM, ARNICA MONTANA ROOT, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM, COMFREY ROOT, MATRICARIA RECUTITA, HAMAMELIS VIRGINIANA LEAF, ECHINACEA PURPUREA, MERCURIUS SOLUBILIS, ACONITUM NAPELLUS ROOT, SYMPHYTUM OFFICINALE WHOLE
Label structure6 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Traumeel ® tablets are an analgesic / anti-inflammatory homeopathic drug product indicated for the treatment of

injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated

symptoms such as pain.

Dosage

DOSAGE & ADMINISTRATION SECTION

Adults and children 4 years and older: 1 tablets per day 3 times per day or as directed by a health practitioner.

For children under 4 years: As directed by a health practitioner.

Allow to completely dissolve in the mouth.

WARNINGS

WARNINGS AND PRECAUTIONS SECTION

Do not use if known sensitivity to Traumeel ® or any of its ingredients exists.

Ingredients

DESCRIPTION SECTION

Active Ingredients:

Ingredient name                  Potency Quantity           Final dilution

Aconitum napellus                    3X                                  30 mg 4X

Arnica montana, radix              2X                                  15 mg 3.3X

Belladonna                              4X                                  75 mg 4.6X

Bellis perennis                         2X                                  6 mg 3.7X

Calendula officinalis                 2X                                  15 mg 3.3X

Chamomilla                            3X                                   24 mg 4.1X

Echinacea                               2X                                   6 mg 3.7X

Echinacea purpurea                 2X                                   6 mg 3.7X

Hamamelis virginiana              2X                                   15 mg 3.3X

Hepar sulphuris calcareum       8X                                    30 mg 9X

Hypericum perforatum            2X                                    3 mg 4X

Mercurius solubilis                  8X                                    30 mg 9X

Millefolium                             3X                                    15 mg 4.3X

Symphytum officinale             8X                                    24 mg 9.1X

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose 6.0 mg

Magnesium sterate 1.5 mg

Traumeel Rx Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Trameel Rx Tablets.jpgTrameel Rx Tablets.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50114-9483-2EA - Each50114-9483d633c333-839b-4812-bded-80688e7ac33812016-12-07

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50114-948350114-9483-2, 50114-9483-3

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
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
ARNICA MONTANA ROOTMUE8Y11327ACTIB
BELLIS PERENNIS2HU33I03UYACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
COMFREY ROOTM9VVZ08EKQACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
HAMAMELIS VIRGINIANA LEAFT07U1161SVACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
ACONITUM NAPELLUS ROOTKPD2N7348XACTIB
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YACTIB

Source Document#

Source XML · Source PDF

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
daa08ff6-384b-4f44-a420-5eb3d09f933fbcca68ac-9c2c-4ee4-9a0a-69c8fbcc15782021-10-18WarningsExact identifier
spl id: daa08ff6-384b-4f44-a420-5eb3d09f933f
spl set id: bcca68ac-9c2c-4ee4-9a0a-69c8fbcc1578

Reported adverse events (FAERS/openFDA)#

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