GASTROTONE- gentiana lutea, sambucus nigra, arsenicum album, kali bichromicum, lycopodium clavatum, phosphorus, pulsatilla bismuthum carbonicum, 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: Gentiana lutea 3X, Sambucus nigra 3X, Arsenicum album 12X, Kali bichromicum 12X, Lycopodium clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum carbonicum 15X.

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

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 INGREDIENTS: Demineralized water, 20% Ethanol

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

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

Dist by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

ENERGIQUE

GASTROTONE

Homeopathic Remedy

1 fl. oz. (30 ml)

Gastrotone

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0355-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/29/2010	08/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/29/2010	08/31/2022

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0355) , api manufacture(57520-0355) , label(57520-0355) , pack(57520-0355)

Revised: 3/2022

Document Id: 0d4103db-4db9-4ad3-a5e1-f4a1fa131795

Set id: ab855a7e-d1be-4b33-addc-295c94b4304c

Version: 4

Effective Time: 20220329

Apotheca Company