Traulevium Pain Relief Tablets

Traulevium Pain Relief Tablets
SPL v4
SPL
SPL Set ID 6123d145-4edf-4ecd-8b30-196e52273127
Route
ORAL
Published
Effective Date 2019-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (4 [hp_X]) Arnica Montana (3 [hp_X]) Aconitum Napellus (8 [hp_X]) Matricaria Recutita (2 [hp_X]) Comfrey Root Calendula Officinalis Flowering Top Hamamelis Virginiana Root Bark/stem Bark Achillea Millefolium Calcium Sulfide Mercurius Solubilis Hypericum Perforatum Bellis Perennis Echinacea Angustifolia Echinacea Purpurea
Inactive Ingredients
Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-10-03
Description

Active ingredients (HPUS*) Each tablet contains as active ingredients: Belladonna 4X 75 mg, Arnica Montana Radix 3X 40 mg, Aconitum Napellus 3X 30 mg, Chamomilla 3X 24 mg, Symphytum Officinale 8X 24 mg, Calendula Officinalis 2X 15 mg, Hamamelis Virginiana 2X 15 mg, Millefolium 3X 15 mg, Hepar Sulphuris Calcareum 8X 15 mg, Mercurius Solubilis 8X 15 mg, Hypericum Perforatum 3X 8 mg, Bellis Perennis 2X 6 mg, Echinacea Angustifolia 2X 6 mg, Echinacea Purpurea 2X 6 mg.

Medication Information

Warnings and Precautions

Warnings

  • If symptoms worsen or persist for more than a week, a healthcare provider should be consulted.
  • Do not use if known sensitivity to Traulevium or any of its ingredients exists.
  • Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a healthcare provider before use.
Indications and Usage

Uses** For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain
Dosage and Administration

Directions

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

Standard Dosage
Adults and children 12 years & 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 & older

1 tablet every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 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.

Description

Active ingredients (HPUS*) Each tablet contains as active ingredients: Belladonna 4X 75 mg, Arnica Montana Radix 3X 40 mg, Aconitum Napellus 3X 30 mg, Chamomilla 3X 24 mg, Symphytum Officinale 8X 24 mg, Calendula Officinalis 2X 15 mg, Hamamelis Virginiana 2X 15 mg, Millefolium 3X 15 mg, Hepar Sulphuris Calcareum 8X 15 mg, Mercurius Solubilis 8X 15 mg, Hypericum Perforatum 3X 8 mg, Bellis Perennis 2X 6 mg, Echinacea Angustifolia 2X 6 mg, Echinacea Purpurea 2X 6 mg.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients Lactose, Magnesium stearate.

Section 51945-4

NDC 70857-002-10

MTP

Traulevium™

PAIN RELIEF TABLETS

Homeopathic Medicine

Compare to Traumeel®. Traumeel is a brand name owned by Biologische Heilmittel Heel GmbH. Traulevium is not associated with the brand owner.

100 Chewable Tablets

Section 53413-1

Questions? Call 1.866.440.7703 or email [email protected]

Made in the USA. Manufactured exclusively for Medical Technology Products, Inc. by OHM pharma Inc.

Medical Technology Products, Inc.

Riviera Beach, FL 33407, USA.

www.traulevium.com

Section 55105-1

Purpose** Relieves joint pain, back pain, muscular pain.

Section 55106-9



Active ingredients (HPUS*)

Each tablet contains as active ingredients: Belladonna 4X 75 mg, Arnica Montana Radix 3X 40 mg, Aconitum Napellus 3X 30 mg, Chamomilla 3X 24 mg, Symphytum Officinale 8X 24 mg, Calendula Officinalis 2X 15 mg, Hamamelis Virginiana 2X 15 mg, Millefolium 3X 15 mg, Hepar Sulphuris Calcareum 8X 15 mg, Mercurius Solubilis 8X 15 mg, Hypericum Perforatum 3X 8 mg, Bellis Perennis 2X 6 mg, Echinacea Angustifolia 2X 6 mg, Echinacea Purpurea 2X 6 mg.

Section 60561-8

Other information

Tamper evident: Use this product only if imprinted shrink seal around the neck and cap is intact. Store tightly closed at room temperature. Protect from light and moisture.

**These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

*The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Structured Label Content

Indications and Usage (34067-9)

Uses** For the temporary relief of:

  • Joint Pain
  • Back Pain
  • Muscular Pain
Dosage and Administration (34068-7)

Directions

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

Standard Dosage
Adults and children 12 years & 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 & older

1 tablet every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 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.

Warnings and Precautions (34071-1)

Warnings

  • If symptoms worsen or persist for more than a week, a healthcare provider should be consulted.
  • Do not use if known sensitivity to Traulevium or any of its ingredients exists.
  • Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a healthcare provider before use.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients Lactose, Magnesium stearate.

Section 51945-4 (51945-4)

NDC 70857-002-10

MTP

Traulevium™

PAIN RELIEF TABLETS

Homeopathic Medicine

Compare to Traumeel®. Traumeel is a brand name owned by Biologische Heilmittel Heel GmbH. Traulevium is not associated with the brand owner.

100 Chewable Tablets

Section 53413-1 (53413-1)

Questions? Call 1.866.440.7703 or email [email protected]

Made in the USA. Manufactured exclusively for Medical Technology Products, Inc. by OHM pharma Inc.

Medical Technology Products, Inc.

Riviera Beach, FL 33407, USA.

www.traulevium.com

Section 55105-1 (55105-1)

Purpose** Relieves joint pain, back pain, muscular pain.

Section 55106-9 (55106-9)



Active ingredients (HPUS*)

Each tablet contains as active ingredients: Belladonna 4X 75 mg, Arnica Montana Radix 3X 40 mg, Aconitum Napellus 3X 30 mg, Chamomilla 3X 24 mg, Symphytum Officinale 8X 24 mg, Calendula Officinalis 2X 15 mg, Hamamelis Virginiana 2X 15 mg, Millefolium 3X 15 mg, Hepar Sulphuris Calcareum 8X 15 mg, Mercurius Solubilis 8X 15 mg, Hypericum Perforatum 3X 8 mg, Bellis Perennis 2X 6 mg, Echinacea Angustifolia 2X 6 mg, Echinacea Purpurea 2X 6 mg.

Section 60561-8 (60561-8)

Other information

Tamper evident: Use this product only if imprinted shrink seal around the neck and cap is intact. Store tightly closed at room temperature. Protect from light and moisture.

**These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

*The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:04.967921 · Updated: 2026-03-14T23:15:14.298659