F03 Fr-rls

Aspen, Arsenicum Album, Diplacus Aurantiacus, Garlic, Lilium Tigrinum, Loquat, Luffa Operculata, Mimulus Guttatus, Penstemon Davidsonii, Prunus Cerasifera, Red Horse Chestnut, Rubus Ursinus, Rockrose, Toxicodendron Diversilobum, Viola Odorata, Watermelon, Yellow Jasmine

Apex Energetics Inc.
Human Otc Drug
NDC 63479-0603

F03 Fr-rls also known as Aspen, Arsenicum Album, Diplacus Aurantiacus, Garlic, Lilium Tigrinum, Loquat, Luffa Operculata, Mimulus Guttatus, Penstemon Davidsonii, Prunus Cerasifera, Red Horse Chestnut, Rubus Ursinus, Rockrose, Toxicodendron Diversilobum, Viola Odorata, Watermelon, Yellow Jasmine is a human otc drug labeled by 'Apex Energetics Inc.'. National Drug Code (NDC) number for F03 Fr-rls is 63479-0603. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in F03 Fr-rls drug includes Aesculus Carnea Flower - 12 [hp_C]/mL Allium Sativum Whole - 12 [hp_C]/mL Arsenic Trioxide - 20 [hp_C]/mL Diplacus Aurantiacus Whole - 12 [hp_C]/mL Eriobotrya Japonica Whole - 12 [hp_C]/mL Gelsemium Sempervirens Root - 20 [hp_C]/mL Helianthemum Nummularium Flower - 12 [hp_C]/mL Lilium Lancifolium Whole Flowering - 20 [hp_C]/mL Luffa Operculata Fruit - 12 [hp_C]/mL Mimulus Guttatus Flowering Top - 12 [hp_C]/mL and more. The currest status of F03 Fr-rls drug is Active.

Drug Information:

Drug NDC:	63479-0603
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:	F03 Fr-rls
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	F03
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	FR-RLS
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:	Aspen, Arsenicum Album, Diplacus Aurantiacus, Garlic, Lilium Tigrinum, Loquat, Luffa Operculata, Mimulus Guttatus, Penstemon Davidsonii, Prunus Cerasifera, Red Horse Chestnut, Rubus Ursinus, Rockrose, Toxicodendron Diversilobum, Viola Odorata, Watermelon, Yellow Jasmine
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 CARNEA FLOWER - 12 [hp_C]/mL ALLIUM SATIVUM WHOLE - 12 [hp_C]/mL ARSENIC TRIOXIDE - 20 [hp_C]/mL DIPLACUS AURANTIACUS WHOLE - 12 [hp_C]/mL ERIOBOTRYA JAPONICA WHOLE - 12 [hp_C]/mL GELSEMIUM SEMPERVIRENS ROOT - 20 [hp_C]/mL HELIANTHEMUM NUMMULARIUM FLOWER - 12 [hp_C]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING - 20 [hp_C]/mL LUFFA OPERCULATA FRUIT - 12 [hp_C]/mL MIMULUS GUTTATUS FLOWERING TOP - 12 [hp_C]/mL Load more... PENSTEMON DAVIDSONII WHOLE - 12 [hp_C]/mL POPULUS TREMULA FLOWERING TOP - 12 [hp_C]/mL PRUNUS CERASIFERA FLOWER - 12 [hp_C]/mL RUBUS URSINUS WHOLE - 12 [hp_C]/mL TOXICODENDRON DIVERSILOBUM WHOLE - 12 [hp_C]/mL VIOLA ODORATA FLOWER - 12 [hp_C]/mL WATERMELON - 12 [hp_C]/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:	24 Dec, 2025
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:	0818960011772
UPC stands for Universal Product Code.
NUI:	N0000185371 N0000175629 N0000184306 M0000728 M0006342 N0000185015
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	717DPT98VM IIF21WT8O3 S7V92P67HO TO6G4140YA 2FCJ9QNJ7O 639KR60Q1Q 51BRR32WPP X67Z2963PI C4MO6809HU 192426I5JU Load more... 8K9DCX606Z 5Q01F7TPJJ 0KD7R09EAS EB3AN7DKSL 9211E5735B 438W01FC7A 231473QB6R
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]
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]
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]
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] Cell-mediated Immunity [PE] Dietary Proteins [CS] Fruit Proteins [EXT] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
63479-0603-1	30 mL in 1 BOTTLE, GLASS (63479-0603-1)	12 Mar, 1996	N/A	No
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.

Other medicines with the same generic name

F03 Fr-rls

Aspen & more..

Solution/ Drops
Apex Energetics Inc.
NDC: 63479-0603

Purpose:

For temporary relief of minor: restlessness* fearfulness* backache* cold sweat* buzzing ears* weak memory* dizziness* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

F03 fr-rls aspen, arsenicum album, diplacus aurantiacus, garlic, lilium tigrinum, loquat, luffa operculata, mimulus guttatus, penstemon davidsonii, prunus cerasifera, red horse chestnut, rubus ursinus, rockrose, toxicodendron diversilobum, viola odorata, watermelon, yellow jasmine arsenic trioxide arsenic cation (3+) viola odorata flower viola odorata flower gelsemium sempervirens root gelsemium sempervirens root eriobotrya japonica whole eriobotrya japonica whole luffa operculata fruit luffa operculata fruit mimulus guttatus flowering top mimulus guttatus flowering top toxicodendron diversilobum whole toxicodendron diversilobum whole penstemon davidsonii whole penstemon davidsonii whole aesculus carnea flower aesculus carnea flower rubus ursinus whole rubus ursinus whole prunus cerasifera flower prunus cerasifera flower allium sativum whole allium sativum whole populus tremula flowering top populus tremula flowering top diplacus aurantiacus whole diplacus aurantiacus whole helianthemum nummularium flower helianthemum nummularium flower watermelon watermelon water alcohol lilium lancifolium whole flowering lilium lancifolium whole flowering

Indications and Usage:

Uses: for temporary relief of minor: restlessness* fearfulness* backache* cold sweat* buzzing ears* weak memory* dizziness* *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 restlessness, fearfulness, backache, cold sweat, buzzing ears, weak memory, dizziness, 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 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 restlessness, fearfulness, backache, cold sweat, buzzing ears, weak memory, dizziness, or other symptoms do not improve within 7 days or are accompanied by fever.

Package Label Principal Display Panel:

FutureplexÂ® f03 flower essences fr-rlsâ¢ homeopathic formula restlessness* fearfulness* 1 fl oz (30 ml) alcohol 20% by volume f0321-0312

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.