Gastrotone

Manufacturer: BioActive Nutritional, Inc. | Apotheca Company
Effective date: 2023-06-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 21:30:17

Label at a glance#

ProductGastrotone

Active ingredientCAPSICUM, FENNEL SEED, COMFREY ROOT, SILVER NITRATE, ARSENIC TRIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PULSATILLA VULGARIS

Label structure9 sections

Indications and uses

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

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS

OTC - PURPOSE SECTION

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

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 cool, dry place.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Demineralized water, 25% Ethanol.

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

QUESTIONS

OTC - QUESTIONS SECTION

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

GASTROTONE

1 FL OZ (30 ml)

Gastrotone

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43857-0186-1	2023-06-08	C162847	48780-1	9d75b9d0-9787-f424-e053-dadaa90a57ce	Drug Facts
43857-0186-1	2020-01-31	C162847	48780-1	9d75b9d0-9787-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARSENIC TRIOXIDE	ACTIVE INGREDIENT	S7V92P67HO	1
CAPSICUM	ACTIVE INGREDIENT	00UK7646FG	1
COMFREY ROOT	ACTIVE INGREDIENT	M9VVZ08EKQ	1
FENNEL SEED	ACTIVE INGREDIENT	G3QC02NIE6	1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	ACTIVE INGREDIENT	HF539G9L3Q	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
SILVER NITRATE	ACTIVE INGREDIENT	95IT3W8JZE	1
ARSENIC CATION (3+)	ACTIVE MOIETY	C96613F5AV	1
CAPSICUM	ACTIVE MOIETY	00UK7646FG	1
COMFREY ROOT	ACTIVE MOIETY	M9VVZ08EKQ	1
FENNEL SEED	ACTIVE MOIETY	G3QC02NIE6	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
SILVER CATION	ACTIVE MOIETY	57N7B0K90A	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Gastrotone
Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Arsenicum Album, Magnesia Phosphorica
CAPSICUM
FENNEL SEED
COMFREY ROOT
SILVER NITRATE
SILVER CATION
ARSENIC TRIOXIDE
ARSENIC CATION (3+)
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
MAGNESIUM CATION
PULSATILLA VULGARIS
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43857-0186	43857-0186-1

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
CAPSICUM	00UK7646FG	ACTIB
FENNEL SEED	G3QC02NIE6	ACTIB
COMFREY ROOT	M9VVZ08EKQ	ACTIB
SILVER NITRATE	95IT3W8JZE	ACTIB
ARSENIC TRIOXIDE	S7V92P67HO	ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	HF539G9L3Q	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d699353e-5cb3-4724-9789-dc7713d72cb4			5f64deee-f0e1-4a9d-a51a-ed14bc13f0d3	2023-06-08	Warnings	Exact identifier spl id: d699353e-5cb3-4724-9789-dc7713d72cb4 spl set id: 5f64deee-f0e1-4a9d-a51a-ed14bc13f0d3

Reported adverse events (FAERS/openFDA)#

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