Label: TRAUMEX- arnica montana whole, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark,baptisia tinctoria root, bellis perennis whole, echinacea angustifolia whole,aconitum napellus whole,matricaria chamomilla whole,achillea millefolium whole,atropa belladonna,hypericum perforatum whole,ruta graveolens flowering top and comfrey root tablet, chewable
- NDC Code(s): 62795-2302-2
- Packager: MediNatura 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 March 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Uses:
- Warnings:
-
Directions:
At first sign of symptoms: Adults and children 4 years
and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then
continue with standard dosage. Standard dosage: Adults and
children 4 years and older: 3 tablets per day, taking 1 tablet every
4-6 hours. Do not exceed 12 tablets in 24 hours. For children
under 4 years, consult your health professional. Allow tablets to
dissolve completely in the mouth, do not swallow - Inactive Ingredients:
- Keep out of reach of children
- Purpose
-
Active Ingredients:
Each tablet contains: *Arnica
montana 3X 150mg, *Calendula officinalis 2X 10mg,
*Hamamelis virginiana 2X 10mg, *Baptisia tinctoria
2X 6mg, *Bellis perennis 2X 6mg, *Echinacea 2X 6mg,
*Aconitum napellus 3X 30mg, *Chamomilla 2X 3mg,
*Millefolium 2X 2mg, *Belladonna 3X 8mg, *Hypericum
perforatum 3X 8mg, *Ruta graveolens 4X 10mg,
*Arnica montana 6X 21mg, *Symphytum officinale 8X
24mg, *Arnica montana 10X 6mg. *Natural - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRAUMEX
arnica montana whole, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark,baptisia tinctoria root, bellis perennis whole, echinacea angustifolia whole,aconitum napellus whole,matricaria chamomilla whole,achillea millefolium whole,atropa belladonna,hypericum perforatum whole,ruta graveolens flowering top and comfrey root tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-2302 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 3 [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] BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 2 [hp_X] BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE 2 [hp_X] ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 2 [hp_X] ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 3 [hp_X] MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 2 [hp_X] ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM WHOLE 2 [hp_X] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_X] HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 3 [hp_X] RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 4 [hp_X] COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 8 [hp_X] Inactive Ingredients Ingredient Name Strength Dextrose (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) Maltodextrin (UNII: 7CVR7L4A2D) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code radiantman Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-2302-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/20/2023 Labeler - MediNatura Inc (079324099) Establishment Name Address ID/FEI Business Operations MediNatura Inc 102783016 manufacture(62795-2302)