FDA.reportPublic FDA data

Lower GI Restoration

Manufacturer
King Bio Inc.
Effective date
2016-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:43

Label at a glance#

ProductLower GI Restoration
Active ingredientAETHUSA CYNAPIUM, GARLIC, BAPTISIA TINCTORIA ROOT, CAPSICUM, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COLLINSONIA CANADENSIS ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, MARSDENIA CONDURANGO BARK, GAMBOGE, GRATIOLA OFFICINALIS, COW MILK, LACTIC ACID, DL-, SODIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, PODOPHYLLUM, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltaum, Sepia, Silicea​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

INDICATIONS & USAGE SECTION

Uses for temporary relief of symptoms of lower gastrointestinal distress: gas bloating, constipation, hemorrhoids, abdominal cramping, diarrhea, flatulence, gastrointestinal inflammation.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

OTC - PURPOSE SECTION

Uses ​for temporary relief of symptoms of lower gastrointestinal distress:

  • gas bloating
  • constipation
  • hemorrhoids
  • abdominal cramping
  • diarrhea
  • flatulence
  • gastrointestinal inflammation

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0322-22020-01-31C16284748780-19d75b9d0-a4ad-f424-e053-dadaa90a57ceLower GI Restoration™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0322-2Lower GI Restoration59 mL in 1 BOTTLE, SPRAYLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0322LOWER GI RESTORATION (AETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTAUM, SEPIA, SILICEA) LIQUID [KING BIO INC.]2Legacy NDC, 1 package rows20160408_985b51b6-32da-433e-9cf7-60f685ead454.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-032257955-0322-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
AETHUSA CYNAPIUMM6936L953CACTIB
GARLICV1V998DC17ACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
CAPSICUM00UK7646FGACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLLINSONIA CANADENSIS ROOTO2630F3XDRACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
MARSDENIA CONDURANGO BARKR23QIR6YBAACTIB
GAMBOGE7556HJ7587ACTIB
GRATIOLA OFFICINALISBDD9991A36ACTIB
COW MILK917J3173FTACTIB
LACTIC ACID, DL-3B8D35Y7S4ACTIB
SODIUM CARBONATE45P3261C7TACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PODOPHYLLUM2S713A4VP3ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML · Source PDF

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
e14b82eb-e686-4fb7-8002-bf1268920aec985b51b6-32da-433e-9cf7-60f685ead4542016-04-08WarningsExact identifier
spl id: e14b82eb-e686-4fb7-8002-bf1268920aec
spl set id: 985b51b6-32da-433e-9cf7-60f685ead454

Reported adverse events (FAERS/openFDA)#

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