TRAUMEX- arnica montana root tablet

Traumex by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

PURPOSE

For the temporary relief of:
Symptoms of bruising
Pain

ACTIVE INGREDIENT

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

Lactose, Magnesium stearate

DIRECTIONS

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRAUMEX 
arnica montana root tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-2300
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	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
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: 62795-2300-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/30/2017

Labeler - MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura		102783016	manufacture(62795-2300)