Label: TRAULEVIUM- belladonna, arnica montana radix, aconitum napellus, chamomilla, symphytum officinale, calendula officinalis, hamamelis virginiana, millefolium, hepar sulphuris calcareum, mercurius solubilis, hypericum perforatum, bellis perennis, echinacea angustifolia, echinacea purpurea. tablet, chewable
- NDC Code(s): 70857-002-10
- Packager: Medical Technology Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 29, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
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.
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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.
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DOSAGE & 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. -
OTHER SAFETY INFORMATION
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.
- INACTIVE INGREDIENT
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QUESTIONS
Questions? Call 1.866.440.7703 or email info@traulevium.com
Made in the USA. Manufactured exclusively for Medical Technology Products, Inc. by OHM pharma Inc.
Medical Technology Products, Inc.
Riviera Beach, FL 33407, USA.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRAULEVIUM
belladonna, arnica montana radix, aconitum napellus, chamomilla, symphytum officinale, calendula officinalis, hamamelis virginiana, millefolium, hepar sulphuris calcareum, mercurius solubilis, hypericum perforatum, bellis perennis, echinacea angustifolia, echinacea purpurea. tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70857-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 4 [hp_X] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X] ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 3 [hp_X] COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 8 [hp_X] CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_X] HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 2 [hp_X] ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 3 [hp_X] CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 8 [hp_X] HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X] BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 2 [hp_X] ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 2 [hp_X] ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 2 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70857-002-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2016 Labeler - Medical Technology Products, Inc. (150890841)
