DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:29

Label at a glance#

ProductGastrotone
Active ingredientCAPSICUM, FENNEL SEED, COMFREY ROOT, SILVER NITRATE, ARSENIC TRIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PULSATILLA VULGARIS WHOLE
Label structure9 sections

Indications and uses

For temporary relief of indigestion, flatulence, nausea, retching, vomiting after eating or drinking; minor burning pain in the stomach, and stomach irritable.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Argentum Nitricum 12X, Arsenicum Album 12X, Capsicum Annuum 3X, Foeniculum Vulgare 3X, Magnesia Phosphorica 12X, Pulsatilla 12X, Symphytum Officinale 6X.

PURPOSE:

OTC - PURPOSE SECTION

Argentum Nitricum – upset stomach,** Arsenicum Album - vomiting,** Capsicum Annuum – burning pains,** Foeniculum Vulgare – gas relief,** Magnesia Phosphorica – cramping pains,** Pulsatilla – stomach pains,** Symphytum Officinale – inflammation**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of indigestion, flatulence, nausea, retching, vomiting after eating or drinking; minor burning pain in the stomach, and stomach irritable.**

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

WARNINGS:

WARNINGS SECTION

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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

GASTROTONE

HOMEOPATHIC

1 fl. oz. (30 mL)

GASTROTONEGASTROTONE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184340544GTIN-13: 0210184340544
EAN-13: 0210184340544
GTIN-12: 210184340544
UPC-A: 210184340544
GTIN storage (14 digits): 00210184340544
BANI0167 Gastrotone 3-4-26.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
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efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0458-1Gastrotone30 mL in 1 BOTTLE, DROPPERLIQUID303

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
43857-045843857-0458-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-05monthly-update2026-06-03 17:58:05

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
GastrotoneCAPSICUM ANNUUM, FOENICULUM VULGARE, SYMPHYTUM OFFICINALE, ARGENTUM NITRICUM, ARSENICUM ALBUM, MAGNESIA PHOSPHORICA, PULSATILLA (VULGARIS)BioActive Nutritional, Inc.1ba810f2-ee90-400c-81d7-d066c5eebe592026-05-07WarningsExact identifier
ndc (package): 43857-0458-1
ndc (product): 43857-0458
ndc11 (package): 43857045801
spl id: eaf2ae33-b4c6-473b-97bd-0f4a7ba4602b
spl set id: 1ba810f2-ee90-400c-81d7-d066c5eebe59

Reported adverse events (FAERS/openFDA)#

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