GASTROTONE (capsicum annuum, foeniculum vulgare, symphytum officinale, argentum nitricum, arsenicum album, magnesia phosphorica, pulsatilla- vulgaris liquid

Gastrotone by

Drug Labeling and Warnings

Gastrotone by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

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

INDICATIONS:

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

WARNINGS:

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.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

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

INDICATIONS:

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

INACTIVE INGREDIENTS

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

GASTROTONE

HOMEOPATHIC

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

GASTROTONE 
capsicum annuum, foeniculum vulgare, symphytum officinale, argentum nitricum, arsenicum album, magnesia phosphorica, pulsatilla (vulgaris) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0458
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	3 [hp_X]  in 1 mL
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6)	FENNEL SEED	3 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0458-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/05/2017

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0458) , api manufacture(43857-0458) , label(43857-0458) , pack(43857-0458)