NDC 43857-0532 Sinus Tonic

Echinacea (angustifolia), Baptisia Tinctoria, Thiaminum Hydrochloricum, Hydrastis Canadensis, Pyridoxinum Hydrochloricum, Spongia Tosta, Apis Mellifica, Ascorbic Acid, Hepar Sulphuris Calcareum, Kali Bichromicum, Lachesis Mutus, Mercurius Iodatus Ruber, Mercurius Sulphuratus Ruber, Pulsatilla (pratensis), Silicea, Sinusitisinum, Pantothenic Acid

NDC Product Code 43857-0532

NDC CODE: 43857-0532

Proprietary Name: Sinus Tonic 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: Echinacea (angustifolia), Baptisia Tinctoria, Thiaminum Hydrochloricum, Hydrastis Canadensis, Pyridoxinum Hydrochloricum, Spongia Tosta, Apis Mellifica, Ascorbic Acid, Hepar Sulphuris Calcareum, Kali Bichromicum, Lachesis Mutus, Mercurius Iodatus Ruber, Mercurius Sulphuratus Ruber, Pulsatilla (pratensis), Silicea, Sinusitisinum, Pantothenic Acid 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.

  • Drug uses not available

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0532-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Sinus Tonic with NDC 43857-0532 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Sinus Tonic is echinacea (angustifolia), baptisia tinctoria, thiaminum hydrochloricum, hydrastis canadensis, pyridoxinum hydrochloricum, spongia tosta, apis mellifica, ascorbic acid, hepar sulphuris calcareum, kali bichromicum, lachesis mutus, mercurius iodatus ruber, mercurius sulphuratus ruber, pulsatilla (pratensis), silicea, sinusitisinum, pantothenic acid. 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.

Sinus Tonic 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 1 [hp_X]/mL
  • BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL
  • THIAMINE HYDROCHLORIDE 4 [hp_X]/mL
  • GOLDENSEAL 5 [hp_X]/mL
  • PYRIDOXINE HYDROCHLORIDE 6 [hp_X]/mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 6 [hp_X]/mL
  • APIS MELLIFERA 12 [hp_X]/mL
  • ASCORBIC ACID 12 [hp_X]/mL
  • CALCIUM SULFIDE 12 [hp_X]/mL
  • POTASSIUM DICHROMATE 12 [hp_X]/mL
  • LACHESIS MUTA VENOM 12 [hp_X]/mL
  • MERCURIC IODIDE 12 [hp_X]/mL
  • MERCURIC SULFIDE 12 [hp_X]/mL
  • ANEMONE PRATENSIS 12 [hp_X]/mL
  • SILICON DIOXIDE 12 [hp_X]/mL
  • SINUSITISINUM 30 [hp_X]/mL
  • PANTOTHENIC ACID 28 [hp_C]/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: 01-02-2020 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: 12-31-2021 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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Sinus Tonic Product Label Images

Sinus Tonic 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 (Angustifolia) 1X, Baptisia Tinctoria 3X, Thiaminum Hydrochloricum 4X, Hydrastis Canadensis 5X, Pyridoxinum Hydrochloricum 6X, Spongia Tosta 6X, Apis Mellifica 12X, Ascorbic Acid 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lachesis Mutus 12X, Mercurius Iodatus Ruber 12X, Mercurius Sulphuratus Ruber 12X, Pulsatilla (Pratensis) 12X, Silicea 12X, Sinusitisinum 30X, 60X, 200X, Pantothenic Acid 28C.

Indications:

For temporary relief of redness and swelling of the nasal passages with post nasal drip, thick, yellowish discharge from the nose, foul smell; frequent coryza alternating with stoppage.

For temporary relief of redness and swelling of the nasal passages with post nasal drip, thick, yellowish discharge from the nose, foul smell; frequent coryza alternating with stoppage.

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 NutritionalSINUS TONICHOMEOPATHIC2 FL OZ (60 ml)

* Please review the disclaimer below.