B03 Sinus Relief

Allium Cepa, Calcarea Iodata, Calcarea Sulphurica, Echinacea Angustifolia, Echinacea Purpurea, Euphorbium Officinarum, Hepar Sulphuris Calcareum, Histaminum Hydrochloricum, Hydrastis Canadensis, Kali Bichromicum, Kali Muriaticum, Kali Sulphuricum, Lac Defloratum, Luffa Operculata, Mercurius Sulphuratus Ruber, Phosphorus, Pulsatilla Vulgaris, Saccharum Lactis, Thuja Occidentalis

Apex Energetics Inc.
Human Otc Drug
NDC 63479-0203

B03 Sinus Relief also known as Allium Cepa, Calcarea Iodata, Calcarea Sulphurica, Echinacea Angustifolia, Echinacea Purpurea, Euphorbium Officinarum, Hepar Sulphuris Calcareum, Histaminum Hydrochloricum, Hydrastis Canadensis, Kali Bichromicum, Kali Muriaticum, Kali Sulphuricum, Lac Defloratum, Luffa Operculata, Mercurius Sulphuratus Ruber, Phosphorus, Pulsatilla Vulgaris, Saccharum Lactis, Thuja Occidentalis is a human otc drug labeled by 'Apex Energetics Inc.'. National Drug Code (NDC) number for B03 Sinus Relief is 63479-0203. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in B03 Sinus Relief drug includes Calcium Iodide - 12 [hp_X]/mL Calcium Sulfate Anhydrous - 12 [hp_X]/mL Calcium Sulfide - 15 [hp_X]/mL Echinacea Angustifolia - 1 [hp_X]/mL Echinacea Purpurea - 1 [hp_X]/mL Euphorbia Resinifera Resin - 6 [hp_X]/mL Goldenseal - 1 [hp_X]/mL Histamine Dihydrochloride - 30 [hp_X]/mL Lactose, Unspecified Form - 12 [hp_X]/mL Luffa Operculata Fruit - 12 [hp_X]/mL and more. The currest status of B03 Sinus Relief drug is Active.

Drug Information:

Drug NDC:	63479-0203
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:	B03 Sinus Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	B03
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Sinus Relief
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:	Allium Cepa, Calcarea Iodata, Calcarea Sulphurica, Echinacea Angustifolia, Echinacea Purpurea, Euphorbium Officinarum, Hepar Sulphuris Calcareum, Histaminum Hydrochloricum, Hydrastis Canadensis, Kali Bichromicum, Kali Muriaticum, Kali Sulphuricum, Lac Defloratum, Luffa Operculata, Mercurius Sulphuratus Ruber, Phosphorus, Pulsatilla Vulgaris, Saccharum Lactis, Thuja Occidentalis
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:	CALCIUM IODIDE - 12 [hp_X]/mL CALCIUM SULFATE ANHYDROUS - 12 [hp_X]/mL CALCIUM SULFIDE - 15 [hp_X]/mL ECHINACEA ANGUSTIFOLIA - 1 [hp_X]/mL ECHINACEA PURPUREA - 1 [hp_X]/mL EUPHORBIA RESINIFERA RESIN - 6 [hp_X]/mL GOLDENSEAL - 1 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 30 [hp_X]/mL LACTOSE, UNSPECIFIED FORM - 12 [hp_X]/mL LUFFA OPERCULATA FRUIT - 12 [hp_X]/mL Load more... MERCURIC SULFIDE - 12 [hp_X]/mL ONION - 12 [hp_X]/mL PHOSPHORUS - 8 [hp_X]/mL POTASSIUM CHLORIDE - 10 [hp_X]/mL POTASSIUM DICHROMATE - 15 [hp_X]/mL POTASSIUM SULFATE - 12 [hp_X]/mL PULSATILLA VULGARIS - 12 [hp_X]/mL SKIM MILK - 30 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG - 10 [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 Feb, 1995
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:	0818960010188
UPC stands for Universal Product Code.
NUI:	N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	8EKI9QEE2H E934B3V59H 1MBW07J51Q VB06AV5US8 QI7G114Y98 1TI1O9028K ZW3Z11D0JV 3POA0Q644U J2B2A4N98G C4MO6809HU Load more... ZI0T668SF1 492225Q21H 27YLU75U4W 660YQ98I10 T4423S18FM 1K573LC5TV I76KB35JEV 6A001Y4M5A 1NT28V9397
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] Vegetable 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] Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Coagulation Factor Activity [PE] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Non-Standardized Food Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC] Vegetable Proteins [CS]
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
63479-0203-1	30 mL in 1 BOTTLE, GLASS (63479-0203-1)	15 Feb, 1995	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

B03 Sinus Relief

Allium Cepa & more..

Solution/ Drops
Apex Energetics Inc.
NDC: 63479-0203

Purpose:

Uses: for temporary relief of minor: sinus congestion* coughing* fatigue* nasal discharge* frontal headache* muscle aches* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

B03 sinus relief allium cepa, calcarea iodata, calcarea sulphurica, echinacea angustifolia, echinacea purpurea, euphorbium officinarum, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, kali bichromicum, kali muriaticum, kali sulphuricum, lac defloratum, luffa operculata, mercurius sulphuratus ruber, phosphorus, pulsatilla vulgaris, saccharum lactis, thuja occidentalis glycerin lactose, unspecified form anhydrous lactose thuja occidentalis leafy twig thuja occidentalis leafy twig potassium sulfate potassium cation goldenseal goldenseal potassium dichromate dichromate ion potassium chloride potassium cation pulsatilla vulgaris pulsatilla vulgaris water phosphorus phosphorus skim milk skim milk calcium iodide calcium cation echinacea angustifolia echinacea angustifolia whole echinacea purpurea echinacea purpurea whole euphorbia resinifera resin euphorbia resinifera resin calcium sulfide calcium sulfide histamine dihydrochloride histamine alcohol mercuric sulfide mercuric cation onion onion calcium sulfate anhydrous calcium cation luffa operculata fruit luffa operculata fruit

Indications and Usage:

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 sinus congestion, coughing, fatigue, nasal discharge, frontal headache, 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 10 drops under the tongue 2-4 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 sinus congestion, coughing, fatigue, nasal discharge, frontal headache, muscle aches, or other symptoms do not improve within 7 days or are accompanied by fever.

Package Label Principal Display Panel:

FutureplexÂ® b03 antitoxÂ® sinus reliefâ¢ homeopathic formula sinus congestion* coughing* 1 fl oz (30 ml) alcohol 13% by volume b0321-0409

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.