Enzyme Restoration

Manufacturer
King Bio Inc
Effective date
2018-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:16

Label at a glance#

ProductEnzyme Restoration
Active ingredientACETIC ACID, AMANITA MUSCARIA FRUITING BODY, ALOE, ANTIMONY TRISULFIDE, SILVER NITRATE, ACTIVATED CHARCOAL, MILK THISTLE, CHELIDONIUM MAJUS, DYSPHANIA AMBROSIOIDES, CINCHONA OFFICINALIS BARK, GRAPHITE, IPECAC, SKIM MILK, MENTHA PIPERITA, STRYCHNOS NUX-VOMICA SEED, CLAVICEPS PURPUREA SCLEROTIUM, TANACETUM VULGARE TOP, TEUCRIUM MARUM, GINGER
Label structure9 sections

Indications and uses

temporarily relieves symptoms of upper gastrointestinal distress: heartburn colic acid indigestion reflux burping belching stomachache nausea constipation bad breath gas lactose intolerance slow digestion flatulence bloating diarrhea burning in stomach vomiting sick headache

Dosage and administration

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 day Use additionally as needed, up to 6 times per day.

Label contents#

Full prescribing information#

​HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

temporarily relieves symptoms of upper gastrointestinal distress:

  • heartburn
  • colic
  • acid indigestion
  • reflux burping
  • belching
  • stomachache
  • nausea
  • constipation
  • bad breath
  • gas
  • lactose intolerance
  • slow digestion
  • flatulence
  • bloating
  • diarrhea
  • burning in stomach
  • vomiting
  • sick headache

​Directions

DOSAGE & ADMINISTRATION SECTION

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 day

Use additionally as needed, up to 6 times per day.

​Warnings

WARNINGS SECTION

​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 SECTION

​Keep out of reach of children

​Other Information

OTHER SAFETY INFORMATION

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

​Purpose

OTC - PURPOSE SECTION

Aceticum acidum......fermentation in stomach, sour belching

Agaricus 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 stoach

Tanacetum vulgare...........burning stomach, headache

Teucrium marum........unnatural appetite, vomiting

Zingiber officinale........stomach rumbling, thirstiness, diarrhea

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-3321-22020-01-31C16284748780-19d75b9d0-ed8b-f424-e053-dadaa90a57ceEnzyme Restoration

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-3321-2Enzyme Restoration59 mL in 1 BOTTLE, SPRAYLIQUID591
57955-3321-2Enzyme Restoration1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-3321ENZYME 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) LIQUID [KING BIO INC]1Legacy NDC, 2 package rows20180308_9de5a5a7-7289-425e-a8e9-2c21e0737f3a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-332157955-3321-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
503989b0-2a41-482b-9cf2-f0c26c37da7e9de5a5a7-7289-425e-a8e9-2c21e0737f3a2018-03-08WarningsExact identifier
spl id: 503989b0-2a41-482b-9cf2-f0c26c37da7e
spl set id: 9de5a5a7-7289-425e-a8e9-2c21e0737f3a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.