NDC 43857-0241 Allergen I

Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Peanut, Black Walnut, Juglans Regia, Almond, Cashew, Coconut, Pecan, Brazil Nut, Lycopersicum Esculentum, Potato, Black Pepper, Eggplant, Gossypium Herbaceum, Flax, Parmesan Cheese, Milk, Beef, Lamb, Pork, Chicken, Egg, Beans, Allium Cepa, Malus Pumila, Flos, Triticum Aestivum, Banana, Fragaria Vesca, Citrus Sinensis, Cod, Tuna, Salmon, Limulus, Oyster, Shrimp, Cortisone Aceticum

NDC Product Code 43857-0241

NDC CODE: 43857-0241

Proprietary Name: Allergen I 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.

Non-Proprietary Name: Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Peanut, Black Walnut, Juglans Regia, Almond, Cashew, Coconut, Pecan, Brazil Nut, Lycopersicum Esculentum, Potato, Black Pepper, Eggplant, Gossypium Herbaceum, Flax, Parmesan Cheese, Milk, Beef, Lamb, Pork, Chicken, Egg, Beans, Allium Cepa, Malus Pumila, Flos, Triticum Aestivum, Banana, Fragaria Vesca, Citrus Sinensis, Cod, Tuna, Salmon, Limulus, Oyster, Shrimp, Cortisone Aceticum 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).
  • Cortisone is a corticosteroid hormone (glucocorticoid). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. This medication is used to treat conditions such as arthritis, blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, and certain cancers.
  • Drug uses not available

NDC Code Structure

  • 43857 - Bioactive Nutritional

NDC 43857-0241-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Allergen I with NDC 43857-0241 is a a human over the counter drug product labeled by Bioactive Nutritional. The generic name of Allergen I is potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, juglans regia, almond, cashew, coconut, pecan, brazil nut, lycopersicum esculentum, potato, black pepper, eggplant, gossypium herbaceum, flax, parmesan cheese, milk, beef, lamb, pork, chicken, egg, beans, allium cepa, malus pumila, flos, triticum aestivum, banana, fragaria vesca, citrus sinensis, cod, tuna, salmon, limulus, oyster, shrimp, cortisone aceticum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional

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.

Allergen I 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.

  • POTASSIUM GLUCONATE 6 [hp_X]/mL
  • BOS TAURUS ADRENAL GLAND 8 [hp_X]/mL
  • BEEF LIVER 8 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • PEANUT 12 [hp_X]/mL
  • BLACK WALNUT 12 [hp_X]/mL
  • ENGLISH WALNUT 12 [hp_X]/mL
  • ALMOND 12 [hp_X]/mL
  • CASHEW 12 [hp_X]/mL
  • COCONUT 12 [hp_X]/mL
  • PECAN 12 [hp_X]/mL
  • BRAZIL NUT 12 [hp_X]/mL
  • SOLANUM LYCOPERSICUM 12 [hp_X]/mL
  • POTATO 12 [hp_X]/mL
  • BLACK PEPPER 12 [hp_X]/mL
  • EGGPLANT 12 [hp_X]/mL
  • LEVANT COTTON SEED 12 [hp_X]/mL
  • FLAX SEED 12 [hp_X]/mL
  • SESAME SEED 12 [hp_X]/mL
  • CASEIN, LACTOCOCCUS LACTIS CULTURED 12 [hp_X]/mL
  • COW MILK 12 [hp_X]/mL
  • BEEF 12 [hp_X]/mL
  • LAMB 12 [hp_X]/mL
  • PORK 12 [hp_X]/mL
  • CHICKEN 12 [hp_X]/mL
  • EGG 12 [hp_X]/mL
  • KIDNEY BEAN 12 [hp_X]/mL
  • ONION 12 [hp_X]/mL
  • MALUS PUMILA FLOWER 12 [hp_X]/mL
  • WHEAT 12 [hp_X]/mL
  • BANANA 12 [hp_X]/mL
  • ALPINE STRAWBERRY 12 [hp_X]/mL
  • ORANGE 12 [hp_X]/mL
  • COD, UNSPECIFIED 12 [hp_X]/mL
  • TUNA, UNSPECIFIED 12 [hp_X]/mL
  • SALMON, UNSPECIFIED 12 [hp_X]/mL
  • LIMULUS POLYPHEMUS 12 [hp_X]/mL
  • OYSTER, UNSPECIFIED 12 [hp_X]/mL
  • SHRIMP, UNSPECIFIED 12 [hp_X]/mL
  • CORTISONE ACETATE 30 [hp_X]/mL
  • HISTAMINE DIHYDROCHLORIDE 30 [hp_X]/mL
  • HYALURONIDASE 30 [hp_X]/mL
  • INTERFERON .GAMMA. PORCINE RECOMBINANT 30 [hp_X]/mL
  • SEROTONIN HYDROCHLORIDE 30 [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: Bioactive Nutritional
Labeler Code: 43857
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: 09-26-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

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.

Allergen I Product Label Images

Allergen I 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:

Potassium Gluconate 6X, Glandula Suprarenalis Bovine 8X, Hepar Bovine 8X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X, Peanut 12X, 30X, Black Walnut12X, 30X, Juglans Regia 12X, 30X, Almond 12X, 30X, Cashew 12X, 30X, Coconut 12X, 30X, Pecan 12X, 30X, Brazil Nut 12X, 30X, Lycopersicum Esculentum 12X, 30X, Potato 12X, 30X, Black Pepper 12X, 30X, Eggplant 12X, 30X, Gossypium Herbaceum 12X, 30X, Flax 12X, 30X, Parmesan Cheese 12X, 30X, Milk 12X, 30X, Beef 12X, 30X, Lamb 12X, 30X, Pork 12X, 30X, Chicken 12X, 30X, Egg 12X, 30X, Beans 12X, 30X, Allium Cepa 12X, 30X, Malus Pumila, Flos 12X, 30X, Triticum Aestivum 12X, 30X, Banana 12X, 30X, Fragaria Vesca 12X, 30X, Citrus Sinensis 12X, 30X, Cod 12X, 30X, Tuna 12X, 30X, Salmon 12X, 30X, Limulus 12X, 30X, Oyster 12X, 30X, Shrimp 12X, 30X, Cortisone Aceticum 30X, Histaminum Hydrochloricum 30X, Hyaluronidase 30X, Interferon (Suis) 30X, Serotonin (Hydrochloride) 30X.

Indications:

For temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.

For temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.

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 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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalALLERGEN IHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.