TRAUMED- arnica root tablet

Traumed by

Drug Labeling and Warnings

Traumed by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS

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

WARNINGS

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

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

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

*Natural ingredients

INACTIVE INGREDIENTS

Inactive Ingredients: Lactose, Magnesium stearate

PURPOSE

Relieves Pain due to:

Overexertion

Bruises

Minor Injury

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRAUMED 
arnica root tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-2301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	Leafman
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-2301-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/30/2014

Labeler - MediNatura Inc. (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura Inc.		102783016	manufacture(62795-2301)