Pneumotone

Lobelia Inflata, Verbascum Thapsus, Balsamum Peruvianum, Antimonium Tartaricum, Arsenicum Album, Drosera (rotundifolia), Kali Bichromicum, Kali Carbonicum, Natrum Sulphuricum, Phosphorous, Spongia Tosta


Energique, Inc.
Human Otc Drug
NDC 44911-0254
Pneumotone also known as Lobelia Inflata, Verbascum Thapsus, Balsamum Peruvianum, Antimonium Tartaricum, Arsenicum Album, Drosera (rotundifolia), Kali Bichromicum, Kali Carbonicum, Natrum Sulphuricum, Phosphorous, Spongia Tosta is a human otc drug labeled by 'Energique, Inc.'. National Drug Code (NDC) number for Pneumotone is 44911-0254. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Pneumotone drug includes Antimony Potassium Tartrate - 12 [hp_X]/mL Arsenic Trioxide - 12 [hp_X]/mL Balsam Peru - 6 [hp_X]/mL Drosera Rotundifolia - 12 [hp_X]/mL Lobelia Inflata - 3 [hp_X]/mL Phosphorus - 12 [hp_X]/mL Potassium Carbonate - 12 [hp_X]/mL Potassium Dichromate - 12 [hp_X]/mL Sodium Sulfate - 12 [hp_X]/mL Spongia Officinalis Skeleton, Roasted - 12 [hp_X]/mL and more. The currest status of Pneumotone drug is Active.

Drug Information:

Drug NDC: 44911-0254
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: Pneumotone
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: Lobelia Inflata, Verbascum Thapsus, Balsamum Peruvianum, Antimonium Tartaricum, Arsenicum Album, Drosera (rotundifolia), Kali Bichromicum, Kali Carbonicum, Natrum Sulphuricum, Phosphorous, Spongia Tosta
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Energique, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:ANTIMONY POTASSIUM TARTRATE - 12 [hp_X]/mL
ARSENIC TRIOXIDE - 12 [hp_X]/mL
BALSAM PERU - 6 [hp_X]/mL
DROSERA ROTUNDIFOLIA - 12 [hp_X]/mL
LOBELIA INFLATA - 3 [hp_X]/mL
PHOSPHORUS - 12 [hp_X]/mL
POTASSIUM CARBONATE - 12 [hp_X]/mL
POTASSIUM DICHROMATE - 12 [hp_X]/mL
SODIUM SULFATE - 12 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED - 12 [hp_X]/mL
VERBASCUM THAPSUS - 3 [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: 31 Aug, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 30 Mar, 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: 10 May, 2026
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:Energique, 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:N0000185508
N0000175629
N0000184306
M0000728
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:DL6OZ476V3
S7V92P67HO
8P5F881OCY
QR44N9XPJQ
9PP1T3TC5U
27YLU75U4W
BQN1B9B9HA
T4423S18FM
0YPR65R21J
1PIP394IID
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 Chemical Allergen [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]
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]
Increased Histamine Release [PE]
Standardized Chemical Allergen [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
44911-0254-130 mL in 1 BOTTLE, DROPPER (44911-0254-1)31 Aug, 201530 Mar, 2025No
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: may temporarily relieve dry hacking cough, hoarseness, bronchial congestion and hay fever symptoms, and difficulty breathing with tightness of chest from congestion of chest.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Pneumotone lobelia inflata, verbascum thapsus, balsamum peruvianum, antimonium tartaricum, arsenicum album, drosera (rotundifolia), kali bichromicum, kali carbonicum, natrum sulphuricum, phosphorous, spongia tosta lobelia inflata lobelia inflata verbascum thapsus verbascum thapsus balsam peru balsam peru antimony potassium tartrate antimony cation (3+) arsenic trioxide arsenic cation (3+) drosera rotundifolia drosera rotundifolia potassium dichromate dichromate ion potassium carbonate carbonate ion sodium sulfate sodium sulfate anhydrous phosphorus phosphorus spongia officinalis skeleton, roasted spongia officinalis skeleton, roasted water alcohol

Indications and Usage:

Indications: may temporarily relieve dry hacking cough, hoarseness, bronchial congestion and hay fever symptoms, and difficulty breathing with tightness of chest from congestion of chest.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Warnings:

Warnings: if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. do not use if tamper evident seal is broken or missing. store in a cool, dry place.

Dosage and Administration:

Directions: adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. if symptoms persist for more than 7 days, consult your health care professional. consult a physician for use in children under 12 years of age.

Package Label Principal Display Panel:

Package label display: energique since 1987 homeopathic remedy pneumotone 1 fl. oz. (30 ml) pneumotone

Further Questions:

Questions: dist. by energique, inc. 201 apple blvd. woodbine, ia 51579 800-869-8078


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.