FDA.reportPublic FDA data

Traumed Tablet

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

Label at a glance#

ProductTraumed
Active ingredientARNICA MONTANA ROOT
Label structure8 sections

Label contents#

Full prescribing information#

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of minor pain due to overexertion, bruises, minor injuries

WARNINGS

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to Traumed® or any of its ingredients exists.

DOSAGE

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.

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

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Each tablet contains: *Arnica montana, radix 6X, 12X, 30X, 200X, 75 mg each.

*Natural ingredients

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Lactose, Magnesium stearate

PURPOSE

OTC - PURPOSE SECTION

Relieves Pain due to:

• Overexertion

• Bruises

• Minor Injury

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Traumed TabletTraumed Tablet

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Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-230162795-2301-2

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
LACTOSEJ2B2A4N98GIACT
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
79e38136-38c2-49cc-9aff-bf058e39d8d4ab31c5d2-8d12-4dbe-be50-362eddd4dd942023-03-06WarningsExact identifier
spl set id: ab31c5d2-8d12-4dbe-be50-362eddd4dd94

Reported adverse events (FAERS/openFDA)#

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