GASTROTONE- gentiana lutea, sambucus nigra, arsenicum album, kali bichromicum, lycopodium clavatum, phosphorus, pulsatilla bismuthum carbonicum, liquid

Gastrotone by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:  Gentiana lutea 3X, Sambucus nigra 3X, Arsenicum album 12X, Kali bichromicum 12X, Lycopodium clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum carbonicum 15X.

PURPOSE

INDICATIONS:  For temporary relief of indigestion, nausea, retching, vomiting after eating or drinking, minor burning pain in the stomach.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Demineralized water, 20% Ethanol

WARNINGS

WARNINGS:  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

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

INDICATIONS:  For temporary relief of indigestion, nausea, retching, vomiting after eating or drinking, minor burning in the stomach.

QUESTIONS

Dist by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

PRINCIPAL DISPLAY PANEL

ENERGIQUE

GASTROTONE

Homeopathic Remedy

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

GASTROTONE 
gentiana lutea, sambucus nigra, arsenicum album, kali bichromicum, lycopodium clavatum, phosphorus, pulsatilla bismuthum carbonicum, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0355
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS)	GENTIANA LUTEA ROOT	3 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM DICHROMATE	12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X]  in 1 mL
BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBCARBONATE	15 [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: 57520-0355-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/29/2010

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture