TRAUMEEL RX- traumeel rx tablet 
MediNatura Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Traumeel Rx Tablet

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

Trameel Rx Tablets.jpg

TRAUMEEL RX 
traumeel rx tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50114-9483
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED2 [hp_X]
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM3 [hp_X]
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT2 [hp_X]
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS2 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM2 [hp_X]
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT8 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF2 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS8 [hp_X]
ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT3 [hp_X]
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y) SYMPHYTUM OFFICINALE WHOLE8 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-9483-21 in 1 CARTON07/01/201604/30/2022
190 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50114-9483-310 in 1 BOTTLE; Type 0: Not a Combination Product03/25/201904/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/201604/30/2022
Labeler - MediNatura Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(50114-9483)

Revised: 10/2021
 
MediNatura Inc