FDA.reportPublic FDA data

Traumex Tablet

Manufacturer
MediNatura Inc | MediNatura
Effective date
2022-08-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:55:05

Label at a glance#

ProductTraumex
Active ingredientARNICA MONTANA ROOT
Label structure8 sections

Indications and uses

Uses: For the temporary relief of minor symptoms of bruising and pain

Dosage and administration

Directions: At first sign of symptoms: Adults and children 4 years and 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. Standard dosage: Adults and children 4 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. For children under 4, consult your health professional. Allow tablets to dissolve completely in the mo...

Label contents#

Full prescribing information#

WARNINGS

WARNINGS SECTION

Warnings: Do not use if pregnant or breast-feeding. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to TraumexTM or any of its ingredients exists.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PURPOSE

OTC - PURPOSE SECTION

For the temporary relief of:
• Symptoms of bruising
• Pain

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Each tablet contains equal parts of *Arnica montana, radix 3X, *Arnica montana, radix 6X , *Arnica montana, radix 12X, *Arnica montana, radix 30X, *Arnica montana, radix 200X *Natural Ingredient

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose, Magnesium stearate

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions:At first sign of symptoms: Adults and children 4 years and 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.

Standard dosage: Adults and children 4 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.
For children under 4, consult your health professional.


Allow tablets to dissolve completely in the mouth, do not swallow.

USES

INDICATIONS & USAGE SECTION

Uses: For the temporary relief of minor symptoms of bruising and pain

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Traumex TabletTraumex Tablet

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Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-230062795-2300-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA ROOTMUE8Y11327ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT

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
54a429a6-75e2-4223-b13c-ff9b5b4c593636a657d5-6004-4549-9d1b-16ae2db4e4f02023-03-06WarningsExact identifier
spl set id: 36a657d5-6004-4549-9d1b-16ae2db4e4f0

Reported adverse events (FAERS/openFDA)#

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