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

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

Active ingredients: Each 2.2 ml contains as Active Ingredients: Arnica montana, radix 3X 22 mcl; Belladonna 3X 22 mcl; Aconitum napellus 3X 13.2 mcl; Hypericum perforatum 3X 6.6 mcl; Calendula officinalis 2X 2.2 mcl; Chamomilla 3X 2.2 mcl; Millefolium 3X 2.2 mcl; Hepar sulphuris calcareum 6X 2.2 mcl; Symphytum officinale 6X 2.2 mcl; Bellis perennis 2X 1.1 mcl; Mercurius solubilis 6X 1.1 mcl; Echinacea 2X 0.55 mcl; Echinacea purpurea 2X 0.55 mcl; Hamamelis virginiana 1X 0.22 mcl each.

INACTIVE INGREDIENTS

Inactive ingredients: Isotonic sodium chloride solution

PURPOSE

Minor Back, Joint and Muscle Pain

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

Indications: For the temporary relief of:

  • Minor Back, Joint and Muscle Pain

WARNINGS

Warnings: If symptoms persist or worsen, a health care professional should be consulted. If pregnant or breast feeding, ask a health care professional before use.

DOSAGE AND ADMINISTRATION

Dosage: Adults and children above 6 years: In general 1 vial orally 1 - 3 times daily, or as directed by a physician. Children up to 6 years: 1/2 vial orally 1 - 3 times daily, or as directed by a physician. Discard unused solution.

Traumeel

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

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50114-1120
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARNICA MONTANA ROOT ARNICA MONTANA ROOT 3 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 3 [hp_X]
ACONITUM NAPELLUS ACONITUM NAPELLUS 3 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 3 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 3 [hp_X]
ACHILLEA MILLEFOLIUM 3 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 6 [hp_X]
COMFREY ROOT COMFREY ROOT 6 [hp_X]
BELLIS PERENNIS Bellis Perennis 2 [hp_X]
MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS 6 [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 1 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2.2 in 1 VIAL
2 NDC:50114-1120-6 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1993-01-31


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