NDC 44911-0521 Allerstat II
Baptisia Tinctoria, Echinacea (angustifolia), Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis, Natrum Sulphuricum, Nux Vomica, Phosphorus, Pulsatilla (pratensis), Solidago Virgaurea, Sulphur Liquid Oral

Product Information

Product Code44911-0521
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Allerstat II
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Baptisia Tinctoria, Echinacea (angustifolia), Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis, Natrum Sulphuricum, Nux Vomica, Phosphorus, Pulsatilla (pratensis), Solidago Virgaurea, Sulphur
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Energique, Inc.
Labeler Code44911
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-20-2020
End Marketing Date 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.
02-11-2025
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 44911-0521-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

Product Details

Allerstat II is a human over the counter drug product labeled by Energique, Inc.. The generic name of Allerstat II is baptisia tinctoria, echinacea (angustifolia), allium cepa, ambrosia artemisiaefolia, arsenicum album, euphrasia officinalis, natrum sulphuricum, nux vomica, phosphorus, pulsatilla (pratensis), solidago virgaurea, sulphur. The product's dosage form is liquid and is administered via oral form.


What are Allerstat II Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Allerstat II Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients:



(in each drop): 9.98% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Euphrasia Officinalis 12X, Natrum Sulphuricum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Solidago Virgaurea 12X, Sulphur 12X;0.10% of Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X.


Indications:



May temporarily relieve sinus congestion due to hay fever and allergic rhinitis.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve sinus congestion due to hay fever and allergic rhinitis.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


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.


Keep Out Of Reach Of Children:



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


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.


Inactive Ingredients:



Demineralized water, 20% Ethanol.


Questions:



Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078


Package Label Display:



ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

ALLERSTAT II

2 fl. oz. (60 ml)


* Please review the disclaimer below.