Cold And Flu Relief

Baptisia Tinctoria, Calcarea Sulphurica, Allium Cepa, Calcarea Carbonica, Calcarea Phosphorica, Ferrum Phosphoricum, Kali Muriaticum, Kali Sulphuricum, Silicea, Spongia Tosta, Aconitum Napellus, Arsenicum Album, Dulcamara, Euphrasia Officinalis, Eupatorium Perfoliatum, Gelsemium Sempervirens


Attuned Matrix, Llc
Human Otc Drug
NDC 71144-0001
Cold And Flu Relief also known as Baptisia Tinctoria, Calcarea Sulphurica, Allium Cepa, Calcarea Carbonica, Calcarea Phosphorica, Ferrum Phosphoricum, Kali Muriaticum, Kali Sulphuricum, Silicea, Spongia Tosta, Aconitum Napellus, Arsenicum Album, Dulcamara, Euphrasia Officinalis, Eupatorium Perfoliatum, Gelsemium Sempervirens is a human otc drug labeled by 'Attuned Matrix, Llc'. National Drug Code (NDC) number for Cold And Flu Relief is 71144-0001. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Cold And Flu Relief drug includes Aconitum Napellus - 12 [hp_X]/mL Arsenic Trioxide - 12 [hp_X]/mL Baptisia Tinctoria Root - 3 [hp_X]/mL Calcium Sulfate Anhydrous - 6 [hp_X]/mL Eupatorium Perfoliatum Flowering Top - 12 [hp_X]/mL Euphrasia Stricta - 12 [hp_X]/mL Ferrum Phosphoricum - 8 [hp_X]/mL Gelsemium Sempervirens Root - 12 [hp_X]/mL Onion - 8 [hp_X]/mL Oyster Shell Calcium Carbonate, Crude - 8 [hp_X]/mL and more. The currest status of Cold And Flu Relief drug is Active.

Drug Information:

Drug NDC: 71144-0001
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: Cold And Flu Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
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: Baptisia Tinctoria, Calcarea Sulphurica, Allium Cepa, Calcarea Carbonica, Calcarea Phosphorica, Ferrum Phosphoricum, Kali Muriaticum, Kali Sulphuricum, Silicea, Spongia Tosta, Aconitum Napellus, Arsenicum Album, Dulcamara, Euphrasia Officinalis, Eupatorium Perfoliatum, Gelsemium Sempervirens
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Attuned Matrix, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Spray
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:ACONITUM NAPELLUS - 12 [hp_X]/mL
ARSENIC TRIOXIDE - 12 [hp_X]/mL
BAPTISIA TINCTORIA ROOT - 3 [hp_X]/mL
CALCIUM SULFATE ANHYDROUS - 6 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP - 12 [hp_X]/mL
EUPHRASIA STRICTA - 12 [hp_X]/mL
FERRUM PHOSPHORICUM - 8 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT - 12 [hp_X]/mL
ONION - 8 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE - 8 [hp_X]/mL
POTASSIUM CHLORIDE - 8 [hp_X]/mL
POTASSIUM SULFATE - 8 [hp_X]/mL
SILICON DIOXIDE - 8 [hp_X]/mL
SOLANUM DULCAMARA TOP - 12 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED - 8 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE - 8 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 19 Jan, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 11 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:Attuned Matrix, LLC
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:N0000185371
N0000175629
N0000184306
M0000728
M0006342
M0022575
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:U0NQ8555JD
S7V92P67HO
5EF0HWI5WU
E934B3V59H
1W0775VX6E
C9642I91WL
91GQH8I5F7
639KR60Q1Q
492225Q21H
2E32821G6I
660YQ98I10
1K573LC5TV
ETJ7Z6XBU4
KPS1B1162N
1PIP394IID
91D9GV0Z28
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
71144-0001-160 mL in 1 BOTTLE, SPRAY (71144-0001-1)19 Jan, 2017N/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:

Indications: for temporary relief of cold and flu symptoms, such as sinus congestion, achiness, chills, headache, sore throat and fever. for best results use at the first sign of a cold or flu.

Product Elements:

Cold and flu relief baptisia tinctoria, calcarea sulphurica, allium cepa, calcarea carbonica, calcarea phosphorica, ferrum phosphoricum, kali muriaticum, kali sulphuricum, silicea, spongia tosta, aconitum napellus, arsenicum album, dulcamara, euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens baptisia tinctoria root baptisia tinctoria root calcium sulfate anhydrous calcium cation onion onion oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude tribasic calcium phosphate calcium cation ferrum phosphoricum ferrosoferric phosphate potassium chloride potassium cation potassium sulfate sulfate ion silicon dioxide silicon dioxide spongia officinalis skeleton, roasted spongia officinalis skeleton, roasted aconitum napellus aconitum napellus arsenic trioxide arsenic cation (3+) solanum dulcamara top solanum dulcamara top euphrasia stricta euphrasia stricta eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top gelsemium sempervirens root gelsemium sempervirens root water alcohol glycerin

Indications and Usage:

Indications: for temporary relief of cold and flu symptoms, such as sinus congestion, achiness, chills, headache, sore throat and fever. for best results use at the first sign of a cold or flu.

Warnings:

Warnings: do not use if you have ever had an allergic reaction to this product or any of its ingredients. stop use and ask a doctor if your symptoms persist, worsen or new symptoms occur. keep out of reach of children. in case of overdose, get medical help or call a poison control center right away. if pregnant or breast feeding, ask a doctor before using product. do not use if tamper evident seal around neck of bottle is missing or broken store at room temperature and keep out of direct sunlight.

Dosage and Administration:

Directions: adults & children over 12 years: spray twice under the tongue three times per day until symptoms are gone. children 12 years and under: consult a doctor prior to use. sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult physician promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Package Label Principal Display Panel:

Package label display: homeopathic cold & flu relief 2.0 fluid oz (60ml) cold & flu relief

Further Questions:

Questions: manufactured for attuned matrix, llc 893 embarcadero drive #102, el dorado hills, ca 95762 (916) 850-5152


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.