B19 Acute Rescue

Aconitum Napellus,apis Mellifica,arnica Montana,arsenicum Album,belladonna,bellis Perennis,bryonia,calendula Officinalis,chamomilla,cherry Plum,clematis Vitalba,colocynthis,comfrey,dulcamara Lignosa,echinacea Angustifolia,echinacea Purpurea,eupatorium Perfoliatum,ferrum Phosphoricum,hamamelis Virginiana,histaminum,hypericum Perforatum,impatiens Glandulifera,ledum Palustre,mentha Piperita,millefolium,ornithogalum Umbellatum,plantago Major,rhus Toxicodendron,rockrose,sulphur,veratrum Album,verbascum Thapsus


Apex Energetics Inc.
Human Otc Drug
NDC 63479-0219
B19 Acute Rescue also known as Aconitum Napellus,apis Mellifica,arnica Montana,arsenicum Album,belladonna,bellis Perennis,bryonia,calendula Officinalis,chamomilla,cherry Plum,clematis Vitalba,colocynthis,comfrey,dulcamara Lignosa,echinacea Angustifolia,echinacea Purpurea,eupatorium Perfoliatum,ferrum Phosphoricum,hamamelis Virginiana,histaminum,hypericum Perforatum,impatiens Glandulifera,ledum Palustre,mentha Piperita,millefolium,ornithogalum Umbellatum,plantago Major,rhus Toxicodendron,rockrose,sulphur,veratrum Album,verbascum Thapsus is a human otc drug labeled by 'Apex Energetics Inc.'. National Drug Code (NDC) number for B19 Acute Rescue is 63479-0219. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in B19 Acute Rescue drug includes Achillea Millefolium - 3 [hp_X]/mL Aconitum Napellus - 30 [hp_X]/mL Apis Mellifera - 12 [hp_X]/mL Arnica Montana - 30 [hp_X]/mL Arsenic Trioxide - 15 [hp_X]/mL Atropa Belladonna - 30 [hp_X]/mL Bellis Perennis - 12 [hp_X]/mL Bryonia Alba Root - 12 [hp_X]/mL Calendula Officinalis Flowering Top - 9 [hp_X]/mL Citrullus Colocynthis Fruit Pulp - 8 [hp_X]/mL and more. The currest status of B19 Acute Rescue drug is Active.

Drug Information:

Drug NDC: 63479-0219
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: B19 Acute Rescue
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: B19
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: ACUTE RESCUE
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Aconitum Napellus,apis Mellifica,arnica Montana,arsenicum Album,belladonna,bellis Perennis,bryonia,calendula Officinalis,chamomilla,cherry Plum,clematis Vitalba,colocynthis,comfrey,dulcamara Lignosa,echinacea Angustifolia,echinacea Purpurea,eupatorium Perfoliatum,ferrum Phosphoricum,hamamelis Virginiana,histaminum,hypericum Perforatum,impatiens Glandulifera,ledum Palustre,mentha Piperita,millefolium,ornithogalum Umbellatum,plantago Major,rhus Toxicodendron,rockrose,sulphur,veratrum Album,verbascum Thapsus
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Apex Energetics Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ACHILLEA MILLEFOLIUM - 3 [hp_X]/mL
ACONITUM NAPELLUS - 30 [hp_X]/mL
APIS MELLIFERA - 12 [hp_X]/mL
ARNICA MONTANA - 30 [hp_X]/mL
ARSENIC TRIOXIDE - 15 [hp_X]/mL
ATROPA BELLADONNA - 30 [hp_X]/mL
BELLIS PERENNIS - 12 [hp_X]/mL
BRYONIA ALBA ROOT - 12 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP - 9 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP - 8 [hp_X]/mL
CLEMATIS VITALBA FLOWER - 30 [hp_X]/mL
COMFREY ROOT - 6 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA - 6 [hp_X]/mL
ECHINACEA PURPUREA - 6 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP - 8 [hp_X]/mL
FERROSOFERRIC PHOSPHATE - 15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 3 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER - 30 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/mL
HYPERICUM PERFORATUM - 6 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER - 30 [hp_X]/mL
LEDUM PALUSTRE TWIG - 1 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE - 8 [hp_X]/mL
MENTHA PIPERITA - 1 [hp_X]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP - 30 [hp_X]/mL
PLANTAGO MAJOR - 1 [hp_X]/mL
PRUNUS CERASIFERA FLOWER - 30 [hp_X]/mL
SOLANUM DULCAMARA WHOLE - 8 [hp_X]/mL
SULFUR - 9 [hp_C]/mL
TOXICODENDRON PUBESCENS LEAF - 12 [hp_X]/mL
VERATRUM ALBUM ROOT - 30 [hp_X]/mL
VERBASCUM THAPSUS - 1 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:SUBLINGUAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 15 Aug, 1988
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 18 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Apex Energetics Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000185021
N0000175629
N0000184306
N0000185001
M0000728
M0002274
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:2FXJ6SW4PK
U0NQ8555JD
7S82P3R43Z
O80TY208ZW
S7V92P67HO
WQZ3G9PF0H
2HU33I03UY
T7J046YI2B
18E7415PXQ
23H32AOH17
7SCP4N87CI
M9VVZ08EKQ
VB06AV5US8
QI7G114Y98
1W0775VX6E
91GQH8I5F7
T7S323PKJS
51BRR32WPP
3POA0Q644U
XK4IUX8MNB
AJU5O1A5ZV
877L01IZ0P
G0R4UBI2ZZ
79M2M2UDA9
CZD6M4PY4B
W2469WNO6U
0KD7R09EAS
G72JA9DHK5
70FD1KFU70
6IO182RP7A
QNS6W5US1Z
C9TD27U172
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Standardized Insect Venom Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Allergens [CS]
Bee Venoms [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Allergens [CS]
Bee Venoms [CS]
Cell-mediated Immunity [PE]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Standardized Insect Venom Allergenic Extract [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63479-0219-130 mL in 1 BOTTLE, SPRAY (63479-0219-1)15 Aug, 1988N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Uses: for temporary relief of minor: inflammation* pain* common cold/flu* bruises* sore throat* muscle aches* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

B19 acute rescue aconitum napellus,apis mellifica,arnica montana,arsenicum album,belladonna,bellis perennis,bryonia,calendula officinalis,chamomilla,cherry plum,clematis vitalba,colocynthis,comfrey,dulcamara lignosa,echinacea angustifolia,echinacea purpurea,eupatorium perfoliatum,ferrum phosphoricum,hamamelis virginiana,histaminum,hypericum perforatum,impatiens glandulifera,ledum palustre,mentha piperita,millefolium,ornithogalum umbellatum,plantago major,rhus toxicodendron,rockrose,sulphur,veratrum album,verbascum thapsus apis mellifera apis mellifera arnica montana arnica montana atropa belladonna atropa belladonna bryonia alba root bryonia alba root prunus cerasifera flower prunus cerasifera flower citrullus colocynthis fruit pulp citrullus colocynthis fruit pulp echinacea purpurea echinacea purpurea echinacea angustifolia echinacea angustifolia ledum palustre twig ledum palustre twig mentha piperita mentha piperita plantago major plantago major ornithogalum umbellatum flowering top ornithogalum umbellatum flowering top toxicodendron pubescens leaf toxicodendron pubescens leaf helianthemum nummularium flower helianthemum nummularium flower histamine dihydrochloride histamine sulfur sulfur comfrey root comfrey root veratrum album root veratrum album root verbascum thapsus verbascum thapsus alcohol water arsenic trioxide arsenic cation (3+) bellis perennis bellis perennis calendula officinalis flowering top calendula officinalis flowering top matricaria chamomilla whole matricaria chamomilla whole eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top ferrosoferric phosphate ferrosoferric phosphate hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark hypericum perforatum hypericum perforatum impatiens glandulifera flower impatiens glandulifera flower achillea millefolium achillea millefolium aconitum napellus aconitum napellus clematis vitalba flower clematis vitalba flower solanum dulcamara whole solanum dulcamara whole

Indications and Usage:

Uses: for temporary relief of minor: inflammation* pain* common cold/flu* bruises* sore throat* muscle aches* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Warnings:

Warnings: if pregnant or breastfeeding , ask a health professional before use. do not use if clear seal over the cap is broken or missing. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. stop use and ask a doctor if inflammation, pain, common cold/flu, bruises, sore throat, muscle aches, or other symptoms do not improve within 7 days or are accompanied by fever.

Dosage and Administration:

Directions: adults & children ages 12 years and over: take 2-3 sprays orally, or topically as directed by your healthcare professional. consult a physician for use in children under 12 years of age.

Stop Use:

Stop use and ask a doctor if inflammation, pain, common cold/flu, bruises, sore throat, muscle aches, or other symptoms do not improve within 7 days or are accompanied by fever.

Package Label Principal Display Panel:

Futureplex® b19 antitox® acute rescue™ spray homeopathic formula inflammation* pain* common cold/flu* 1 fl oz (30 ml) alcohol 10% by volume b19 acute rescue spray 20201201

Further Questions:

Distributed by apex energetics. questions? 16592 hale ave., irvine, ca 92606, usa


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.