NDC 43857-0460 Ob Metab

Fucus Vesiculosus, Capsicum Annuum, Nicotinamidum, Spongia Tosta, Croton Tiglium, Hypophysis Suis, L-arginine, L-ornithine, L-tyrosine, Thyroidinum (suis), Calcarea Carbonica, Graphites, Kali Carbonicum

NDC Product Code 43857-0460

NDC CODE: 43857-0460

Proprietary Name: Ob Metab 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: Fucus Vesiculosus, Capsicum Annuum, Nicotinamidum, Spongia Tosta, Croton Tiglium, Hypophysis Suis, L-arginine, L-ornithine, L-tyrosine, Thyroidinum (suis), Calcarea Carbonica, Graphites, Kali Carbonicum 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.

  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.
  • Drug uses not available

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0460-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Ob Metab with NDC 43857-0460 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Ob Metab is fucus vesiculosus, capsicum annuum, nicotinamidum, spongia tosta, croton tiglium, hypophysis suis, l-arginine, l-ornithine, l-tyrosine, thyroidinum (suis), calcarea carbonica, graphites, kali carbonicum. 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.

Ob Metab 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.

  • FUCUS VESICULOSUS 1 [hp_X]/mL
  • CAPSICUM 3 [hp_X]/mL
  • NIACINAMIDE 5 [hp_X]/mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 5 [hp_X]/mL
  • CROTON TIGLIUM SEED 6 [hp_X]/mL
  • ARGININE 6 [hp_X]/mL
  • ORNITHINE 6 [hp_X]/mL
  • TYROSINE 6 [hp_X]/mL
  • SUS SCROFA PITUITARY GLAND 6 [hp_X]/mL
  • SUS SCROFA THYROID 6 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL
  • GRAPHITE 12 [hp_X]/mL
  • POTASSIUM CARBONATE 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: 09-08-2017 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.

Ob Metab Product Label Images

Ob Metab 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:

Fucus Vesiculosus 1X, Capsicum Annuum 3X, Nicotinamidum 5X, Spongia Tosta 5X, Croton Tiglium 6X, Hypophysis Suis 6X, L-Arginine 6X, L-Ornithine 6X, L-Tyrosine 6X, Thyroidinum (Suis) 6X, Calcarea Carbonica 12X, Graphites 12X, Kali Carbonicum 12X.

Indications:

For the temporary relief of constipation and flatulence, and mental sluggishness with tendency toward obesity.

For the temporary relief of constipation and flatulence, and mental sluggishness with tendency toward obesity.

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 Display Label:

BIOActive NutritionalOB MetabHOMEOPATHIC1 FL OZ (30 ml)

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