TRAUMEEL- aconitum napellus, arnica montana root, atropa belladonna, bellis perennis, calendula officinalis flowering top, chamomile, echinacea, unspecified, echinacea purpurea, hamamelis virginiana root bark/stem bark, calcium sulfide, hypericum perforatum, mercurius solubilis, achillea millefolium and comfrey root 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.

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Traumeel Tablets

KEEP OUT OF REACH OF CHILDREN

 Keep out of reach of children.

INDICATIONS AND USAGE

For the temporary relief of minor:

  • Joint pain
  • Back Pain
  • Muscular Pain

WARNINGS

If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to Traumeel® or any of its ingredients exists. Keep out of reach of children. If pregnant or breastfeeding, ask a healthcare provider before use.

DOSAGE AND ADMINISTRATION

Standard Dosage:

Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.

Children 4 to 11 years: 2 tablets per day, taking 1 tablet every 6 to 8 hours.

Children under 4 years, consult your healthcare provider.

Initial Dosage:

Adults and children 12 years and older: 1 tablet every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceeed 12 tablets in 24 hours.

Children 4 to 11 years: 1 tablet every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 8 tablets in 24 hours.

Children under 4 years, consult your healthcare provider.

Allow tablets to dissolve completely in the mouth, do not swallow.

ACTIVE INGREDIENTS


Each tablet contains as active ingredients: Aconitum napellus 3X, Arnica montana, radix 3X, Belladonna 4X, Bellis perennis 2X, Calendula officinalis 2X, Chamomilla 3X, Echinacea 2X, Echinacea purpurea 2X,  Hamamelis virginiana 2X, Hepar sulphuris calcareum 8X, Hypericum perforatum 3X, Mercurius solubilis 8X,  Millefolium 3X, Symphytum officinale 8X

INACTIVE INGREDIENTS

Lactose, Magnesium stearate

PURPOSE

Aconitum napellus 3X ..................Reduces joint and back pain

Arnica montana, radix 3X ............Reduces joint and back pain

Belladonna 4X .............................Reduces back pain

Bellis perennis 2X ........................Relieves joint and muscle soreness

Calendula officinalis 2X ...............Relieves pain

Chamomilla 3X ............................Soothing pain relief

Echinacea 2X ..............................Relieves pain

Echinacea purpurea 2X ..............Relieves pain

Hamamelis virginiana 2X .............Relieves joint and muscle soreness

Hepar sulphuris calcareum 8X ....Relieves pain

Hypericum perforatum 3X ...........Relieves pain

Mercurius solubilis 8X .................Reduces joint and back pain

Millefolium 3X .............................Relieves pain

Symphytum officinale 8X ............Relieves joint pain

Traumeel Tablet v.5.jpg

TRAUMEEL 
aconitum napellus, arnica montana root, atropa belladonna, bellis perennis, calendula officinalis flowering top, chamomile, echinacea, unspecified, echinacea purpurea, hamamelis virginiana root bark/stem bark, calcium sulfide, hypericum perforatum, mercurius solubilis, achillea millefolium and comfrey root tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-6150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [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]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE3 [hp_X]
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED2 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS8 [hp_X]
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM3 [hp_X]
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT8 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code Heel
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-6150-315 in 1 BOTTLE; Type 0: Not a Combination Product01/31/198409/30/2014
2NDC:50114-6150-515 in 1 BLISTER PACK; Type 0: Not a Combination Product01/31/198409/30/2014
3NDC:50114-6150-61 in 1 CARTON01/31/198409/30/2014
3100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/198409/30/2014
Labeler - MediNatura Inc. (102783016)
Establishment
NameAddressID/FEIBusiness Operations
MediNatura Inc102783016manufacture(50114-6150)

Revised: 1/2017
Document Id: 7154b772-abc5-4bea-908b-7262add684c2
Set id: 26f9a844-b464-4779-9ca7-3fdc5a7a901d
Version: 6
Effective Time: 20170104
 
MediNatura Inc.