NDC 43857-0379 Somineze

Humulus Lupulus, Passiflora Incarnata, Valeriana Officinalis, Ambrosia Artemisiaefolia, Arsenicum Album, Coffea Tosta, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Silicea

NDC Product Code 43857-0379

NDC 43857-0379-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Somineze with NDC 43857-0379 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Somineze is humulus lupulus, passiflora incarnata, valeriana officinalis, ambrosia artemisiaefolia, arsenicum album, coffea tosta, lycopodium clavatum, nux vomica, phosphoricum acidum, silicea. 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.

Somineze 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.

  • HOPS 3 [hp_X]/mL
  • PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X]/mL
  • VALERIAN 3 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA 12 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • COFFEA ARABICA SEED, ROASTED 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • PHOSPHORIC ACID 12 [hp_X]/mL
  • SILICON DIOXIDE 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: 10-14-2015 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.

Somineze Product Label Images

Somineze 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:

Humulus Lupulus 3X, Passiflora Incarnata 3X, Valeriana Officinalis 3X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Coffea Tosta 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Silicea 12X.

Indications:

For temporary relief of fatigue, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.

For temporary relief of fatigue, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.

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 NUTRITIONALMelbourne, FL 32935For Nutritional Information write:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935

Package Label Display:

BIOActive NutritionalSOMINEZEHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.