Label: TRAUMEEL RX- 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.

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  • 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.

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  • WARNINGS

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

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  • 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

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  • INACTIVE INGREDIENT

    Lactose 6.0 mg

    Magnesium sterate 1.5 mg

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  • 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)
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