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Traumeel

Heel Inc

Traumeel Oral Drop


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 pregnant or breast-feeding, ask a healthcare provider before use. Keep out of reach of children. 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.

TRAUMEEL DOSAGE AND ADMINISTRATION

Standard Dosage:

Adults and children 12 years and older: 30 drops per day, taking 10 drops every 4 to 6 hours.

Children under 12 years: Consult your healthcare provider.

Initial Dosage:

Adults and children 12 years and older: 10 drops every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceeed 120 drops in 24 hours.

Child ren under 12 years: Consult your healthcare provider.

If used in children below 18 years for more than 14 days, contact a healthcare provider as these drops contain alcohol.

ACTIVE INGREDIENTS

Each 10 drops 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

Ethanol, Purified Water

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

Traumeel

ACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM and COMFREY ROOT LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50114-1160
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS ACONITUM NAPELLUS 3 [hp_X]
ARNICA MONTANA ROOT ARNICA MONTANA ROOT 3 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 4 [hp_X]
BELLIS PERENNIS Bellis Perennis 2 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 3 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 2 [hp_X]
ECHINACEA PURPUREA 2 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 2 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 8 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 3 [hp_X]
MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS 8 [hp_X]
ACHILLEA MILLEFOLIUM 3 [hp_X]
COMFREY ROOT COMFREY ROOT 8 [hp_X]

Inactive Ingredients

Ingredient Name Strength
water
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:50114-1160-4 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1986-01-31


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Be sure to consult your doctor before taking any medication!
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