Label: TRAUMEEL RX tablet

  • NDC Code(s): 50114-9483-2, 50114-9483-3
  • Packager: MediNatura Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated March 12, 2019

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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 CARTON07/01/2016
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50114-9483-310 in 1 BOTTLE; Type 0: Not a Combination Product03/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2016
    Labeler - MediNatura Inc (102783016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biologische Heilmittel Heel315635359manufacture(50114-9483)