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Allergen ii - Prescription Drug Labeling

Product NDC Code 43857-0145
Drug Name

Allergen ii

Type Brand
Active Ingredients
Potassium gluconate 6 [hp_x]/ml
Epinephrine 8 [hp_x]/ml
Beef liver 8 [hp_x]/ml
Rumex acetosella pollen 9 [hp_x]/ml
Rumex crispus top 9 [hp_x]/ml
Poa pratensis top 9 [hp_x]/ml
Dactylis glomerata top 9 [hp_x]/ml
Agrostis gigantea pollen 9 [hp_x]/ml
Phleum pratense top 9 [hp_x]/ml
Solidago virgaurea flowering top 9 [hp_x]/ml
Trifolium pratense flower 9 [hp_x]/ml
Alfalfa 9 [hp_x]/ml
Ambrosia acanthicarpa pollen 9 [hp_x]/ml
Ambrosia artemisiifolia 9 [hp_x]/ml
Ambrosia trifida pollen 9 [hp_x]/ml
Ambrosia psilostachya pollen 9 [hp_x]/ml
Fraxinus americana pollen 9 [hp_x]/ml
Fagus grandifolia pollen 9 [hp_x]/ml
Betula occidentalis pollen 9 [hp_x]/ml
Acer negundo pollen 9 [hp_x]/ml
Populus deltoides subsp. deltoides pollen 9 [hp_x]/ml
Ulmus americana pollen 9 [hp_x]/ml
Carya ovata pollen 9 [hp_x]/ml
Quercus rubra pollen 9 [hp_x]/ml
Platanus occidentalis pollen 9 [hp_x]/ml
Juglans nigra pollen 9 [hp_x]/ml
Salix nigra pollen 9 [hp_x]/ml
Arsenic trioxide 12 [hp_x]/ml
Phosphorus 12 [hp_x]/ml
Pulsatilla vulgaris 12 [hp_x]/ml
Sulfur 12 [hp_x]/ml
Histamine dihydrochloride 30 [hp_x]/ml
Route ORAL
Dosage Form LIQUID
Labeler Name BioActive Nutritional, Inc.
Packages
Package NDC Code Description
43857-0145-1 30 ml in 1 bottle, dropper (43857-0145-1)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS: Kali Gluconicum 6X, Adrenalinum 8X, Hepar (Bovinum) 8X, Sheep Sorrel 9X, 12X, 30X, Yellow Dock 9X, 12X, 30X, Kentucky Blue Grass 9X, 12X, 30X, Orchard Grass 9X, 12X, 30X, Red Top Grass 9X, 12X, 30X, Timothy Grass 9X, 12X, 30X, Solidago Virgaurea 9X, 12X, 30X, Trifolium Pratense 9X, 12X, 30X, Alfalfa 9X, 12X, 30X, False Ragweed 9X, 12X, 30X, Short Ragweed 9X, 12X, 30X, Tall Ragweed 9X, 12X, 30X, Western Ragweed 9X, 12X, 30X, Ash 9X, 12X, 30X, Beech 9X, 12X, 30X, Red Birch 9X, 12X, 30X, Box Elder 9X, 12X, 30X, Cottonwood 9X, 12X, 30X, Elm 9X, 12X, 30X, Hickory 9X, 12X, 30X, Red Oak 9X, 12X, 30X, Sycamore 9X, 12X, 30X, Black Walnut 9X, 12X, 30X, Black Willow 9X, 12X, 30X, Arsenicum Album 12X, Phosphorus 12X, Pulsatilla 12X, Sulphur 12X, Histaminum Hydrochloricum 30X.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
INDICATIONS: For temporary relief of sinus congestion, symptoms due to hay fever and allergic rhinitis.

Purpose

Information about the drug product’s indications for use.
INDICATIONS: For temporary relief of sinus congestion, symptoms due to hay fever and allergic rhinitis.

Spl product data elements

Usually a list of ingredients in a drug product.
Allergen II Kali Gluconicum, Adrenalinum, Hepar, Sheep Sorrel, Yellow Dock, Kentucky Blue Grass, Orchard Grass, Red Top Grass, Timothy Grass, Goldenrod, Red Clover, False Ragweed, Short Ragweed, Tall Ragweed, Western Ragweed, Ash, Beech, Red Birch, Box Elder, Cottonwood, Elm, Hickory, Red Oak, Sycamore, Black Walnut, Black Willow, Arsenicum Album, Phosphorus, Pulsatilla, Sulphur, Histaminum Hydrochloricum POTASSIUM GLUCONATE POTASSIUM CATION EPINEPHRINE EPINEPHRINE BEEF LIVER BEEF LIVER RUMEX ACETOSELLA POLLEN RUMEX ACETOSELLA POLLEN RUMEX CRISPUS TOP RUMEX CRISPUS TOP POA PRATENSIS TOP POA PRATENSIS TOP DACTYLIS GLOMERATA TOP DACTYLIS GLOMERATA TOP AGROSTIS GIGANTEA POLLEN AGROSTIS GIGANTEA POLLEN PHLEUM PRATENSE TOP PHLEUM PRATENSE TOP SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP TRIFOLIUM PRATENSE FLOWER TRIFOLIUM PRATENSE FLOWER ALFALFA ALFALFA AMBROSIA ACANTHICARPA POLLEN AMBROSIA ACANTHICARPA POLLEN AMBROSIA ARTEMISIIFOLIA AMBROSIA ARTEMISIIFOLIA AMBROSIA TRIFIDA POLLEN AMBROSIA TRIFIDA POLLEN AMBROSIA PSILOSTACHYA POLLEN AMBROSIA PSILOSTACHYA POLLEN FRAXINUS AMERICANA POLLEN FRAXINUS AMERICANA POLLEN FAGUS GRANDIFOLIA POLLEN FAGUS GRANDIFOLIA POLLEN BETULA OCCIDENTALIS POLLEN BETULA OCCIDENTALIS POLLEN ACER NEGUNDO POLLEN ACER NEGUNDO POLLEN POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN POPULUS DELTOIDES POLLEN ULMUS AMERICANA POLLEN ULMUS AMERICANA POLLEN CARYA OVATA POLLEN CARYA OVATA POLLEN QUERCUS RUBRA POLLEN QUERCUS RUBRA POLLEN PLATANUS OCCIDENTALIS POLLEN PLATANUS OCCIDENTALIS POLLEN JUGLANS NIGRA POLLEN JUGLANS NIGRA POLLEN SALIX NIGRA POLLEN SALIX NIGRA BARK ARSENIC TRIOXIDE ARSENIC CATION (3+) PHOSPHORUS PHOSPHORUS PULSATILLA VULGARIS PULSATILLA VULGARIS SULFUR SULFUR HISTAMINE DIHYDROCHLORIDE HISTAMINE WATER ALCOHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL DISPLAY: BIO Active Nutritional ALLERGEN II HOMEOPATHIC 1FL OZ (30 ml) Allergen II

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
QUESTIONS: Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com *For a complete list of Pollen Allersodes contact BioActive Nutritional, Inc.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS: If pregnant or breast-feeding, ask a health care 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 cool, dry place.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API