NDC 57955-3321 Enzyme Restoration

Aceticum Acidum, Agaricus Muscarius, Aloe, Antimonium Crudum, Argentum Nitricum, Carbo Vegetabilis, Carduus Marianus, Chelidonium Majus, Chenopodium Anthelminticum, Cinchona Officinalis, Graphites, Ipecacuanha, Lac Defloratum, Mentha Piperita, Nux Vomica, Secale Cornutum, Tanacetum Vulgare, Teucrium Marum, Zingiber Officinale

NDC Product Code 57955-3321

NDC Code: 57955-3321

Proprietary Name: Enzyme Restoration 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: Aceticum Acidum, Agaricus Muscarius, Aloe, Antimonium Crudum, Argentum Nitricum, Carbo Vegetabilis, Carduus Marianus, Chelidonium Majus, Chenopodium Anthelminticum, Cinchona Officinalis, Graphites, Ipecacuanha, Lac Defloratum, Mentha Piperita, Nux Vomica, Secale Cornutum, Tanacetum Vulgare, Teucrium Marum, Zingiber Officinale 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

  • 57955 - King Bio Inc
    • 57955-3321 - Enzyme Restoration

NDC 57955-3321-2

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Enzyme Restoration with NDC 57955-3321 is a a human over the counter drug product labeled by King Bio Inc. The generic name of Enzyme Restoration is aceticum acidum, agaricus muscarius, aloe, antimonium crudum, argentum nitricum, carbo vegetabilis, carduus marianus, chelidonium majus, chenopodium anthelminticum, cinchona officinalis, graphites, ipecacuanha, lac defloratum, mentha piperita, nux vomica, secale cornutum, tanacetum vulgare, teucrium marum, zingiber officinale. The product's dosage form is liquid and is administered via oral form.

Labeler Name: King Bio 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.

Enzyme Restoration 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.

  • ACETIC ACID 10 [hp_X]/59mL
  • AMANITA MUSCARIA FRUITING BODY 10 [hp_X]/59mL
  • ALOE 10 [hp_X]/59mL
  • ANTIMONY TRISULFIDE 10 [hp_X]/59mL
  • SILVER NITRATE 10 [hp_X]/59mL
  • ACTIVATED CHARCOAL 10 [hp_X]/59mL
  • MILK THISTLE 10 [hp_X]/59mL
  • CHELIDONIUM MAJUS 10 [hp_X]/59mL
  • DYSPHANIA AMBROSIOIDES 10 [hp_X]/59mL
  • CINCHONA OFFICINALIS BARK 10 [hp_X]/59mL
  • GRAPHITE 10 [hp_X]/59mL
  • IPECAC 10 [hp_X]/59mL
  • SKIM MILK 10 [hp_X]/59mL
  • MENTHA PIPERITA 10 [hp_X]/59mL
  • STRYCHNOS NUX-VOMICA SEED 10 [hp_X]/59mL
  • CLAVICEPS PURPUREA SCLEROTIUM 10 [hp_X]/59mL
  • TANACETUM VULGARE TOP 10 [hp_X]/59mL
  • TEUCRIUM MARUM 10 [hp_X]/59mL
  • GINGER 10 [hp_X]/59mL

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)
  • CARYA OVATA BARK (UNII: X765CF609L)
  • CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)
  • REBAUDIOSIDE A (UNII: B3FUD0528F)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: King Bio Inc
Labeler Code: 57955
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: 03-08-2018 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: 12-31-2019 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.

Enzyme Restoration Product Label Images

Enzyme Restoration 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

​Hpus Active Ingredients

Aceticum acidum, Agaricus muscarius, Aloe, Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Carduus marianus, Chelidonium majus, Chenopodium anthelminticum, Cinchona officinalis, Graphites, Ipecacuanha, Lac defloratum, Mentha piperita, Nux vomica, Secale cornutum, Tanacetum vulgare, Teucrium marum, Zingiber officinale

Uses

  • Temporarily relieves symptoms of upper gastrointestinal distress:heartburncolicacid indigestionreflux burpingbelchingstomachachenauseaconstipationbad breathgaslactose intoleranceslow digestionflatulencebloatingdiarrheaburning in stomachvomitingsick headache

​Directions

Intially, depress pump until primed.Spray one dose directly into mouth.​Adults: 3 sprays 3 times per day.​Children ages 2-12: 2 sprays 3 times per dayUse additionally as needed, up to 6 times per day.

​Warnings

​If symptoms persist or worsen, ​seek advice of a physician.​If pregnant or breast-feeding, ​ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

​Keep out of reach of children

​Other Information

Tamper resistant for your protection. Use only if safety seal is intact.

​Purpose

Aceticum acidum......fermentation in stomach, sour belchingAgaricus muscarius.....gastric disturbance with diarrhea Aloe....flatulence and nausea with headache Antimonium crudum....heartburn, intestinal complaints Argentum nitricum........belching bloating Carbo vegetabilis...........nausea Carduus marianus.........constipation, sour stomach Chelidonium majus.........stomach pain, colic Chenopodium anthelminticum.......bad breath, loss of appetite Cinchona officinalis............gas, slow digestion, lactose intolerances Graphites..........flatulence, diarrhea, burning in stomach Ipecacuanha.......nausea, vomiting Lac defloratum.........constipation, sick headache Mentha piperita.............indigestion Nux vomica.......sensitive stomach, bloating, sour taste Secale cornutum.............excessive thirst or appetite, nausea, burning in stoachTanacetum vulgare...........burning stomach, headacheTeucrium marum........unnatural appetite, vomitingZingiber officinale........stomach rumbling, thirstiness, diarrhea

​Inactive Ingredients

Bio-Energetically Enhanced​TM ​pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica(honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

* Please review the disclaimer below.

Previous Code
57955-3320
Next Code
57955-3322