NDC 43857-0314 Pms

Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Hypothalamus Suis, Magnesium Gluconicum Dihydricum, Oophorinum (suis) Pyridoxinum Hydrochloricum, Bovista, Cuprum Metallicum, Sepia, Zincum Metallicum, Lachesis Mutus

NDC Product Code 43857-0314

NDC CODE: 43857-0314

Proprietary Name: Pms 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: Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Hypothalamus Suis, Magnesium Gluconicum Dihydricum, Oophorinum (suis) Pyridoxinum Hydrochloricum, Bovista, Cuprum Metallicum, Sepia, Zincum Metallicum, Lachesis Mutus 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.

  • This medication is a mineral supplement used to prevent and treat low amounts of magnesium in the blood. Some brands are also used to treat symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion. Magnesium is very important for the normal functioning of cells, nerves, muscles, bones, and the heart. Usually, a well-balanced diet provides normal blood levels of magnesium. However, certain situations cause your body to lose magnesium faster than you can replace it from your diet. These situations include treatment with water pills (diuretics such as furosemide, hydrochlorothiazide), a poor diet, alcoholism, or other medical conditions (e.g., severe diarrhea/vomiting, stomach/intestinal absorption problems, poorly controlled diabetes).
  • Drug uses not available
  • Drug uses not available

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0314-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Pms with NDC 43857-0314 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Pms is angelica archangelica, cimicifuga racemosa, fucus vesiculosus, hypothalamus suis, magnesium gluconicum dihydricum, oophorinum (suis) pyridoxinum hydrochloricum, bovista, cuprum metallicum, sepia, zincum metallicum, lachesis mutus. 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.

Pms 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.

  • ANGELICA ARCHANGELICA ROOT 3 [hp_X]/mL
  • BLACK COHOSH 3 [hp_X]/mL
  • FUCUS VESICULOSUS 3 [hp_X]/mL
  • SUS SCROFA HYPOTHALAMUS 6 [hp_X]/mL
  • MAGNESIUM GLUCONATE 6 [hp_X]/mL
  • SUS SCROFA OVARY 6 [hp_X]/mL
  • PYRIDOXINE HYDROCHLORIDE 6 [hp_X]/mL
  • LYCOPERDON UTRIFORME FRUITING BODY 12 [hp_X]/mL
  • COPPER 12 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 12 [hp_X]/mL
  • ZINC 12 [hp_X]/mL
  • LACHESIS MUTA VENOM 15 [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: 07-14-2014 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.

Pms Product Label Images

Pms 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:

Angelica Archangelica 3X, Cimicifuga Racemosa 3X, Fucus Vesiculosus 3X, Hypothalamus (Suis) 6X, Magnesium Gluconicum Dihydricum 6X, Oophorinum (Suis) 6X, Pyridoxinum Hydrochloricum 6X, Bovista 12X, Cuprum Metallicum 12X, Sepia 12X, Zincum Metallicum 12X, Lachesis Mutus 15X.

Indications:

For temporary relief of fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

For temporary relief of fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

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 NutritionalPMSHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.