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Traumeel Rx Tablet

Package insert / prescribing information
Generic name: homeopathic product
Dosage form: tablet

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.

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

TRAUMEEL RX
Traumeel Rx Tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50114-9483
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 4 [hp_X]
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 2 [hp_X]
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM 3 [hp_X]
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 2 [hp_X]
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 2 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_X]
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 2 [hp_X]
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 8 [hp_X]
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 3 [hp_X]
HAMAMELIS VIRGINIANA LEAF (HAMAMELIS VIRGINIANA LEAF) HAMAMELIS VIRGINIANA LEAF 2 [hp_X]
ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA 2 [hp_X]
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 8 [hp_X]
ACONITUM NAPELLUS ROOT (ACONITUM NAPELLUS ROOT) ACONITUM NAPELLUS ROOT 3 [hp_X]
SYMPHYTUM OFFICINALE WHOLE (SYMPHYTUM OFFICINALE WHOLE) SYMPHYTUM OFFICINALE WHOLE 8 [hp_X]
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code H
Contains
Packaging
# Item Code Package Description
1 NDC:50114-9483-2 1 BOTTLE in 1 CARTON
1 90 TABLET in 1 BOTTLE
2 NDC:50114-9483-3 10 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2016 04/30/2022
Labeler - MediNatura Inc (102783016)
Establishment
Name Address ID/FEI Operations
Biologische Heilmittel Heel 315635359 manufacture(50114-9483)
MediNatura Inc