NDC 43857-0583 Respitory Tonic F
Echinacea (angustifolia), Uva-ursi, Baptisia Tinctoria, Convallaria Majalis, Kali Muriaticum, Pinus Sylvestris, Thuja Occidentalis, Bryonia (alba), Condurango, Crotalus Horridus, Ginkgo Biloba, Lachesis Mutus, Selenium Metallicum, Tabebuia Impetiginosa, Viscum Album
NDC Product Code 43857-0583
Proprietary Name: Respitory Tonic F 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), Uva-ursi, Baptisia Tinctoria, Convallaria Majalis, Kali Muriaticum, Pinus Sylvestris, Thuja Occidentalis, Bryonia (alba), Condurango, Crotalus Horridus, Ginkgo Biloba, Lachesis Mutus, Selenium Metallicum, Tabebuia Impetiginosa, Viscum Album 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.
NDC Code Structure
- 43857 - Bioactive Nutritional, Inc.
- 43857-0583 - Respitory Tonic F
NDC 43857-0583-1
Package Description: 60 mL in 1 BOTTLE, DROPPER
NDC Product Information
Respitory Tonic F with NDC 43857-0583 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Respitory Tonic F is echinacea (angustifolia), uva-ursi, baptisia tinctoria, convallaria majalis, kali muriaticum, pinus sylvestris, thuja occidentalis, bryonia (alba), condurango, crotalus horridus, ginkgo biloba, lachesis mutus, selenium metallicum, tabebuia impetiginosa, viscum album. The product's dosage form is liquid and is administered via oral form.
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.
Respitory Tonic F 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.
- ARCTOSTAPHYLOS UVA-URSI LEAF 1 [hp_X]/mL
- BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL
- BRYONIA ALBA ROOT 12 [hp_X]/mL
- CONVALLARIA MAJALIS 6 [hp_X]/mL
- CROTALUS HORRIDUS HORRIDUS VENOM 12 [hp_X]/mL
- ECHINACEA ANGUSTIFOLIA WHOLE 1 [hp_X]/mL
- GINKGO 12 [hp_X]/mL
- LACHESIS MUTA VENOM 12 [hp_X]/mL
- MARSDENIA CONDURANGO BARK 12 [hp_X]/mL
- PINUS SYLVESTRIS LEAFY TWIG 6 [hp_X]/mL
- POTASSIUM CHLORIDE 6 [hp_X]/mL
- SELENIUM 12 [hp_X]/mL
- TABEBUIA IMPETIGINOSA BARK 12 [hp_X]/mL
- THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL
- VISCUM ALBUM FRUITING TOP 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.
Pharmacological Class(es)
What is a Pharmacological Class?These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Potassium Compounds - [CS]
- Potassium Salt - [EPC] (Established Pharmacologic Class)
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: 05-10-2021 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: 12-31-2022 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 - NO 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".
* Please review the disclaimer below.
Respitory Tonic F Product Label Images
Respitory Tonic F 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:
- Indications:
- Warnings:
- Keep Out Of Reach Of Children:
- Directions:
- Inactive Ingredients:
- Questions:
- Package Label Display:
Active Ingredients:
Echinacea (Angustifolia) 1X, Uva-Ursi 1X, Baptisia Tinctoria 3X, Convallaria Majalis 6X, Kali Muriaticum 6X, Pinus Sylvestris 6X, Thuja Occidentalis 6X, Bryonia (Alba) 12X, Condurango 12X, Crotalus Horridus 12X, Ginkgo Biloba 12X, Lachesis Mutus 12X, Selenium Metallicum 12X, Tabebuia Impetiginosa 12X, Viscum Album 12X.
Indications:
For temporary relief of various strains of influenza.
For temporary relief of various strains of influenza.
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 NutritionalRESPITORY TONIC FHOMEOPATHIC2 FL OZ (60 ml)
* Please review the disclaimer below.