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Traumeel Rx Tablet Prescribing Information

Package insert / product label
Generic name: homeopathic product
Dosage form: tablet

Indications and Usage for Traumeel Rx Tablet

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.

Traumeel Rx Tablet Dosage and Administration

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 and Precautions

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

Traumeel Rx Tablet Description

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 CodeH
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)