NDC 43857-0389 Grain And Seed Antigens

Bamboo, Barley, California Poppy, Corn, Flax, Levant Cotton, Millet, Milo, Oat, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower, Wheat, Arsenicum Album, Lycopodium Clavatum, Natrum Muriaticum, Sulphur

NDC Product Code 43857-0389

NDC CODE: 43857-0389

Proprietary Name: Grain And Seed Antigens 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: Bamboo, Barley, California Poppy, Corn, Flax, Levant Cotton, Millet, Milo, Oat, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower, Wheat, Arsenicum Album, Lycopodium Clavatum, Natrum Muriaticum, Sulphur 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).
  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0389-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Grain And Seed Antigens with NDC 43857-0389 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Grain And Seed Antigens is bamboo, barley, california poppy, corn, flax, levant cotton, millet, milo, oat, rice, rye, safflower, sesame, sorghum, soy bean, sugarcane, sunflower, wheat, arsenicum album, lycopodium clavatum, natrum muriaticum, sulphur. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, 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.

Grain And Seed Antigens 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.

  • BAMBUSA VULGARIS LEAF 9 [hp_X]/mL
  • BARLEY 9 [hp_X]/mL
  • ESCHSCHOLZIA CALIFORNICA 9 [hp_X]/mL
  • CORN 9 [hp_X]/mL
  • FLAX SEED 9 [hp_X]/mL
  • LEVANT COTTON SEED 9 [hp_X]/mL
  • MILLET 9 [hp_X]/mL
  • SORGHUM BICOLOR WHOLE 9 [hp_X]/mL
  • OAT 9 [hp_X]/mL
  • BROWN RICE 9 [hp_X]/mL
  • RYE 9 [hp_X]/mL
  • SAFFLOWER 9 [hp_X]/mL
  • SESAME SEED 9 [hp_X]/mL
  • SOYBEAN 9 [hp_X]/mL
  • SUGARCANE 9 [hp_X]/mL
  • SUNFLOWER SEED 9 [hp_X]/mL
  • WHEAT 9 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • SODIUM CHLORIDE 12 [hp_X]/mL
  • SULFUR 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: Bioactive Nutritional, Inc.
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: 04-22-2016 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’.

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Grain And Seed Antigens Product Label Images

Grain And Seed Antigens 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:

Bamboo 9X, 12X, 15X, 30X, Barley 9X, 12X, 15X, 30X, California Poppy 9X, 12X, 15X, 30X, Corn 9X, 12X, 15X, 30X, Flax 9X, 12X, 15X, 30X, Levant Cotton 9X, 12X, 15X, 30X, Millet 9X, 12X, 15X, 30X, Milo 9X, 12X, 15X, 30X, Oat 9X, 12X, 15X, 30X, Rice 9X, 12X, 15X, 30X, Rye 9X, 12X, 15X, 30X, Safflower 9X, 12X, 15X, 30X, Sesame 9X, 12X, 15X, 30X, Sorghum 9X, 12X, 15X, 30X, Soy Bean 9X, 12X, 15X, 30X, Sugarcane 9X, 12X, 15X, 30X, Sunflower 9X, 12X, 15X, 30X, Wheat 9X, 12X, 15X, 30X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Sulphur 12X

Indications:

For temporary relief of allergies due to grain and seeds.

For temporary relief of allergies due to grain and seeds.

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.

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 NutritionalGRAIN & SEED ANTIGENSHOMEOPATHIC1 FL OZ (30 ml)

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