NDC 43857-0417 Endoplex F

Cimicifuga Racemosa, Fucus Vesiculosus, Glycyrrhiza Glabra, Xanthoxylum Fraxineum, Adrenalinum, Cerebrum Suis, Hypophysis Suis, Hypothalamus (suis), Oophorinum (suis), Pineal (suis), Thyroidinum (suis), Pulsatilla (vulgaris), Sepia

NDC Product Code 43857-0417

NDC Product Information

Endoplex F with NDC 43857-0417 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Endoplex F is cimicifuga racemosa, fucus vesiculosus, glycyrrhiza glabra, xanthoxylum fraxineum, adrenalinum, cerebrum suis, hypophysis suis, hypothalamus (suis), oophorinum (suis), pineal (suis), thyroidinum (suis), pulsatilla (vulgaris), sepia. 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.

Endoplex 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.

  • BLACK COHOSH 3 [hp_X]/mL
  • FUCUS VESICULOSUS 3 [hp_X]/mL
  • GLYCYRRHIZA GLABRA 3 [hp_X]/mL
  • ZANTHOXYLUM AMERICANUM BARK 3 [hp_X]/mL
  • EPINEPHRINE 8 [hp_X]/mL
  • SUS SCROFA CEREBRUM 8 [hp_X]/mL
  • SUS SCROFA PITUITARY GLAND 8 [hp_X]/mL
  • SUS SCROFA HYPOTHALAMUS 8 [hp_X]/mL
  • SUS SCROFA OVARY 8 [hp_X]/mL
  • SUS SCROFA PINEAL GLAND 8 [hp_X]/mL
  • SUS SCROFA THYROID 8 [hp_X]/mL
  • PULSATILLA VULGARIS 12 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 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: 09-29-2016 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’.

* Please review the disclaimer below.

Endoplex F Product Label Images

Endoplex 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:

Cimicifuga Racemosa 3X, Fucus Vesiculosus 3X, Glycyrrhiza Glabra 3X, Xanthoxylum Fraxineum 3X, Adrenalinum 8X, Cerebrum Suis 8X, Hypophysis Suis 8X, Hypothalamus (Suis) 8X, Oophorinum (Suis) 8X, Pineal (Suis) 8X, Thyroidinum (Suis) 8X, Pulsatilla (Vulgaris) 12X, Sepia 12X.

Indications:

For temporary relief of menstrual pain and cramps, pain immediately prior to menses, and sore tender breasts associated with menstruation.

For temporary relief of menstrual pain and cramps, pain immediately prior to menses, and sore tender breasts associated with menstruation.

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 NutritionalENDOPLEX FHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.