Traumeel description, usages, side effects, indications, overdosage, supplying and lots more!

Traumeel

Heel Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Traumeel Tablets

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 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

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 Type Human otc drug label Item Code (Source) NDC:50114-6150
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]
CHAMOMILE CHAMOMILE 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
LACTOSE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white 9 mm Heel ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50114-6150-3 15 in 1 BOTTLE
2 NDC:50114-6150-5 15 in 1 BLISTER PACK
3 100 in 1 BOTTLE
4 NDC:50114-6150-6 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1984-01-31


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Be sure to consult your doctor before taking any medication!
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