F18 Rlxtn

Apricot, Chamomile, Coffea Arabica, Coffea Cruda, Comfrey, Crimson Monkey, Date Palm, Dill, English Elm Ing Twig, European Aspen, Filaree, Golden Eardrops, Horse Chestnut, Humulus Lupulus, Hypericum Perforatum, Hypericum Perforatum Flower, Impatiens Glandulifera, Magnesia Phosphorica, Mexican Pink, Mimulus Guttatus, Nux Vomica, Oregon Grapeholly, Passiflora Incarnata, Scutellaria Lateriflora, Sweet Chestnut, Verbena Officinalis, Watermelon, Yerba Santa, Zincum Valerianicum


Apex Energetics Inc.
Human Otc Drug
NDC 63479-0618
F18 Rlxtn also known as Apricot, Chamomile, Coffea Arabica, Coffea Cruda, Comfrey, Crimson Monkey, Date Palm, Dill, English Elm Ing Twig, European Aspen, Filaree, Golden Eardrops, Horse Chestnut, Humulus Lupulus, Hypericum Perforatum, Hypericum Perforatum Flower, Impatiens Glandulifera, Magnesia Phosphorica, Mexican Pink, Mimulus Guttatus, Nux Vomica, Oregon Grapeholly, Passiflora Incarnata, Scutellaria Lateriflora, Sweet Chestnut, Verbena Officinalis, Watermelon, Yerba Santa, Zincum Valerianicum is a human otc drug labeled by 'Apex Energetics Inc.'. National Drug Code (NDC) number for F18 Rlxtn is 63479-0618. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in F18 Rlxtn drug includes Aesculus Hippocastanum Flower - 12 [hp_C]/mL Anethum Graveolens Whole - 12 [hp_C]/mL Arabica Coffee Bean - 15 [hp_X]/mL Berberis Aquifolium Whole - 12 [hp_C]/mL Calochortus Gunnisonii Whole - 12 [hp_C]/mL Castanea Sativa Flower - 12 [hp_C]/mL Coffea Arabica Whole - 12 [hp_C]/mL Ehrendorferia Chrysantha Whole - 12 [hp_C]/mL Eriodictyon Californicum Flowering Top - 12 [hp_C]/mL Erodium Cicutarium - 12 [hp_C]/mL and more. The currest status of F18 Rlxtn drug is Active.

Drug Information:

Drug NDC: 63479-0618
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: F18 Rlxtn
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: F18
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: RLXTN
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: Apricot, Chamomile, Coffea Arabica, Coffea Cruda, Comfrey, Crimson Monkey, Date Palm, Dill, English Elm Ing Twig, European Aspen, Filaree, Golden Eardrops, Horse Chestnut, Humulus Lupulus, Hypericum Perforatum, Hypericum Perforatum Flower, Impatiens Glandulifera, Magnesia Phosphorica, Mexican Pink, Mimulus Guttatus, Nux Vomica, Oregon Grapeholly, Passiflora Incarnata, Scutellaria Lateriflora, Sweet Chestnut, Verbena Officinalis, Watermelon, Yerba Santa, Zincum Valerianicum
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:AESCULUS HIPPOCASTANUM FLOWER - 12 [hp_C]/mL
ANETHUM GRAVEOLENS WHOLE - 12 [hp_C]/mL
ARABICA COFFEE BEAN - 15 [hp_X]/mL
BERBERIS AQUIFOLIUM WHOLE - 12 [hp_C]/mL
CALOCHORTUS GUNNISONII WHOLE - 12 [hp_C]/mL
CASTANEA SATIVA FLOWER - 12 [hp_C]/mL
COFFEA ARABICA WHOLE - 12 [hp_C]/mL
EHRENDORFERIA CHRYSANTHA WHOLE - 12 [hp_C]/mL
ERIODICTYON CALIFORNICUM FLOWERING TOP - 12 [hp_C]/mL
ERODIUM CICUTARIUM - 12 [hp_C]/mL
ERYTHRANTHE CARDINALIS WHOLE - 12 [hp_C]/mL
HOPS - 4 [hp_X]/mL
HYPERICUM PERFORATUM - 4 [hp_X]/mL
HYPERICUM PERFORATUM FLOWER - 12 [hp_C]/mL
IMPATIENS GLANDULIFERA FLOWER - 12 [hp_C]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 10 [hp_X]/mL
MATRICARIA RECUTITA FLOWERING TOP - 12 [hp_C]/mL
MIMULUS GUTTATUS FLOWERING TOP - 12 [hp_C]/mL
PASSIFLORA INCARNATA FLOWERING TOP - 4 [hp_X]/mL
PHOENIX DACTYLIFERA WHOLE - 12 [hp_C]/mL
POPULUS TREMULA FLOWERING TOP - 12 [hp_C]/mL
PRUNUS ARMENIACA WHOLE - 12 [hp_C]/mL
SCUTELLARIA LATERIFLORA WHOLE - 6 [hp_X]/mL
SILENE LACINIATA WHOLE - 12 [hp_C]/mL
STRYCHNOS NUX-VOMICA SEED - 10 [hp_X]/mL
SYMPHYTUM OFFICINALE WHOLE - 12 [hp_C]/mL
ULMUS PROCERA FLOWERING TWIG - 12 [hp_C]/mL
VERBENA OFFICINALIS FLOWERING TOP - 12 [hp_C]/mL
WATERMELON - 12 [hp_C]/mL
ZINC VALERATE DIHYDRATE - 12 [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: 12 Mar, 1996
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 06 May, 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.
UPC:0818960010348
UPC stands for Universal Product Code.
NUI:N0000185371
N0000185375
N0000175629
N0000184306
M0000728
M0006342
M0016962
M0516536
M0008672
N0000185001
N0000185015
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:KK0Z92II8M
BWN6849791
3SW678MX72
J4WG1JVR05
H4ORZ75P00
YHZ719F7M3
90J8498ESR
68HKD4QMJR
HKE3DK7994
FJL3XFK3N8
4MGZ04S7LT
01G73H6H83
XK4IUX8MNB
A6V4CUE7PV
AJU5O1A5ZV
HF539G9L3Q
3VNC7T6Z02
192426I5JU
CLF5YFS11O
8QI9RWU9M1
5Q01F7TPJJ
10TCS27K2T
7BP4DH5PDC
565ZR7YWT0
269XH13919
H8FJJ6KX5Y
J3O020I532
311PNK9CDZ
231473QB6R
MN0RX54EQA
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:Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant 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]
Dietary Proteins [CS]
Plant Proteins [CS]
Seed Storage Proteins [CS]
Food Additives [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]
Calculi Dissolution Agent [EPC]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Food Additives [CS]
Fruit Proteins [EXT]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Plant Proteins [CS]
Seed Storage Proteins [CS]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63479-0618-130 mL in 1 BOTTLE, GLASS (63479-0618-1)12 Mar, 1996N/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: nervous irritability* exhaustion* worry* neck and back tension* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

F18 rlxtn apricot, chamomile, coffea arabica, coffea cruda, comfrey, crimson monkey, date palm, dill, english elm ing twig, european aspen, filaree, golden eardrops, horse chestnut, humulus lupulus, hypericum perforatum, hypericum perforatum flower, impatiens glandulifera, magnesia phosphorica, mexican pink, mimulus guttatus, nux vomica, oregon grapeholly, passiflora incarnata, scutellaria lateriflora, sweet chestnut, verbena officinalis, watermelon, yerba santa, zincum valerianicum impatiens glandulifera flower impatiens glandulifera flower silene laciniata whole silene laciniata whole hypericum perforatum flower hypericum perforatum flower anethum graveolens whole anethum graveolens whole aesculus hippocastanum flower aesculus hippocastanum flower prunus armeniaca whole prunus armeniaca whole erythranthe cardinalis whole erythranthe cardinalis whole symphytum officinale whole symphytum officinale whole matricaria recutita flowering top matricaria recutita flowering top coffea arabica whole coffea arabica whole arabica coffee bean arabica coffee bean phoenix dactylifera whole phoenix dactylifera whole ehrendorferia chrysantha whole ehrendorferia chrysantha whole castanea sativa flower castanea sativa flower hypericum perforatum hypericum perforatum strychnos nux-vomica seed strychnos nux-vomica seed berberis aquifolium whole berberis aquifolium whole passiflora incarnata flowering top passiflora incarnata flowering top verbena officinalis flowering top verbena officinalis flowering top water scutellaria lateriflora whole scutellaria lateriflora whole watermelon watermelon eriodictyon californicum flowering top eriodictyon californicum flowering top zinc valerate dihydrate valeric acid alcohol ulmus procera flowering twig ulmus procera flowering twig populus tremula flowering top populus tremula flowering top erodium cicutarium erodium cicutarium calochortus gunnisonii whole calochortus gunnisonii whole hops hops magnesium phosphate, dibasic trihydrate magnesium cation mimulus guttatus flowering top mimulus guttatus flowering top

Indications and Usage:

Uses: for temporary relief of minor: nervous irritability* exhaustion* worry* neck and back tension* *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 nervous irritability, exhaustion, worry, neck and back tension, 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 10 drops under the tongue 2-3 times a day, or 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 nervous irritability, exhaustion, worry, neck and back tension, or other symptoms do not improve within 7 days or are accompanied by fever.

Package Label Principal Display Panel:

Futureplex® f18 flower essences rlxtn™ homeopathic formula nervous irritability* exhaustion* worry* 1 fl oz (30 ml) alcohol 20% by volume f18 flxtn 20200923 label

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.