Traumeel Rx by MediNatura Inc / Biologische Heilmittel Heel TRAUMEEL RX tablet

Traumeel Rx by

Drug Labeling and Warnings

Traumeel Rx by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc, Biologische Heilmittel Heel. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Ingredients

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

Lactose 6.0 mg

Magnesium sterate 1.5 mg

Traumeel Rx Tablets

INGREDIENTS AND APPEARANCE

TRAUMEEL RX 
traumeel rx tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50114-9483
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X]
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	2 [hp_X]
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	3 [hp_X]
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	2 [hp_X]
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	2 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	2 [hp_X]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	2 [hp_X]
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	8 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV)	HAMAMELIS VIRGINIANA LEAF	2 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	2 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	8 [hp_X]
ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X)	ACONITUM NAPELLUS ROOT	3 [hp_X]
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	8 [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	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50114-9483-2	1 in 1 CARTON	07/01/2016
1		90 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50114-9483-3	10 in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2016

Labeler - MediNatura Inc (102783016)

Establishment
Name	Address	ID/FEI	Business Operations
Biologische Heilmittel Heel		315635359	manufacture(50114-9483)