GASTROTONE- capsicum, fennel seed, comfrey root, silver nitrate, arsenic trioxide, magnesium phosphate, dibasic trihydrate and pulsatilla vulgaris liquid
Apotheca Company

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Gastrotone

ACTIVE INGREDIENTS: Capsicum annuum 3X, Foeniculum vulgare 3X, Symphytum officinale 3X, Argentum nitricum 12X, Arsenicum album 12X, Magnesia phosphorica 12X, Pulsatilla 12X.

INDICATIONS: For temporary relief of indigestion, flatulence, nausea, retching, vomiting 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 a 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 & USAGE:

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

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

GASTROTONE

1 FL OZ (30 ml)

Gastrotone

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0552
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	3 [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) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0552-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/21/2010	07/30/2015

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0552) , api manufacture(57520-0552) , label(57520-0552) , recovery(57520-0552)

Revised: 9/2015

Document Id: 483671de-fba4-4449-aad2-6c6afbde5985

Set id: 95c1b77f-fe75-4d83-99a5-f52e475496c9

Version: 2

Effective Time: 20150910

Apotheca Company