Gastrotone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:24

Label at a glance#

ProductGastrotone
Active ingredientGENTIANA LUTEA ROOT, SAMBUCUS NIGRA FLOWERING TOP, ARSENIC TRIOXIDE, POTASSIUM DICHROMATE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, PULSATILLA PRATENSIS WHOLE, BISMUTH SUBNITRATE
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 16.63% of Arsenicum Album 12X, Bismuthum Subnitricum 15X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X; 0.10% of Gentiana Lutea 3X, Sambucus Nigra 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve indigestion, nausea, retching, vomiting after eating or drinking, and minor burning in the stomach.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve indigestion, nausea, retching, vomiting after eating or drinking, and minor burning in the stomach.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GASTROTONE

1 fl. oz. (30 ml)

GastrotoneGastrotone

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0563-12024-10-24C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0563-12024-01-30C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0563-12022-06-28C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0563-12022-01-28C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0563-1Gastrotone30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0563GASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20241027_3e93ca93-0c1e-4305-bf0f-efd44c30a9d3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-056344911-0563-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
GastrotoneGENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUMEnergique, Inc.3e93ca93-0c1e-4305-bf0f-efd44c30a9d32024-10-24WarningsExact identifier
ndc (package): 44911-0563-1
ndc (product): 44911-0563
ndc11 (package): 44911056301
spl id: 4d7a01db-50f9-482e-b8d7-fbb87386968f
spl set id: 3e93ca93-0c1e-4305-bf0f-efd44c30a9d3

Reported adverse events (FAERS/openFDA)#

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