NDC 44911-0036 Sinutone

Echinachea, Hydrastis Canadensis, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Kali Bichromicum, Nux Moschata

NDC Product Information

Sinutone with NDC 44911-0036 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Sinutone is echinachea, hydrastis canadensis, allium cepa, ambrosia artemisiaefolia, arsenicum album, kali bichromicum, nux moschata. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sinutone Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ECHINACEA ANGUSTIFOLIA 12 [hp_X]/mL
  • GOLDENSEAL 3 [hp_X]/mL
  • ONION 12 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA 12 [hp_X]/mL
  • PULSATILLA VULGARIS 12 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 12 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • POTASSIUM DICHROMATE 12 [hp_X]/mL
  • NUTMEG 12 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Energique, Inc.
Labeler Code: 44911
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-05-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 07-21-2020 What is the End Marketing Date?
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.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sinutone Product Label Images

Sinutone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Echinacea 3X, Hydrastis Canadensis 3X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla 12X, Sepia 12X, Solidago Virgaurea 12X.

Indications

For temporary relief of allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities and postnasal drip. These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

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.

Directions

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

Demineralized water, 20% Ethanol.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications And Usage

For temporary relief of allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities and postnasal drip. These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Questions

Dist. by Energique, Inc.201 Apple BlvdWoodbine, IA 51579800-869-8078

* Please review the disclaimer below.