Gastrotone
- Manufacturer
- Apotheca Company
- Effective date
- 2022-03-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:04:49
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: Gentiana lutea 3X, Sambucus nigra 3X, Arsenicum album 12X, Kali bichromicum 12X, Lycopodium clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum carbonicum 15X.
OTC - PURPOSE SECTION
INDICATIONS: For temporary relief of indigestion, nausea, retching, vomiting after eating or drinking, minor burning pain in the stomach.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol
WARNINGS SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
INDICATIONS: For temporary relief of indigestion, nausea, retching, vomiting after eating or drinking, minor burning in the stomach.
OTC - QUESTIONS SECTION
Dist by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579
800-869-8078
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ENERGIQUE
GASTROTONE
Homeopathic Remedy
1 fl. oz. (30 ml)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57520-0355-1 | 2022-03-29 | C162847 | 48780-1 | 9d75b9d0-8a0a-f424-e053-dadaa90a57ce | Gastrotone |
| 57520-0355-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8a0a-f424-e053-dadaa90a57ce | Gastrotone |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARSENIC TRIOXIDE | ACTIVE INGREDIENT | S7V92P67HO | 3 | |
| BISMUTH SUBCARBONATE | ACTIVE INGREDIENT | M41L2IN55T | 3 | |
| GENTIANA LUTEA ROOT | ACTIVE INGREDIENT | S72O3284MS | 3 | |
| LYCOPODIUM CLAVATUM SPORE | ACTIVE INGREDIENT | C88X29Y479 | 3 | |
| PHOSPHORUS | ACTIVE INGREDIENT | 27YLU75U4W | 3 | |
| POTASSIUM DICHROMATE | ACTIVE INGREDIENT | T4423S18FM | 3 | |
| PULSATILLA VULGARIS | ACTIVE INGREDIENT | I76KB35JEV | 3 | |
| SAMBUCUS NIGRA FLOWERING TOP | ACTIVE INGREDIENT | CT03BSA18U | 3 | |
| ARSENIC TRIOXIDE | ACTIVE MOIETY | S7V92P67HO | 3 | |
| BISMUTH CATION | ACTIVE MOIETY | ZS9CD1I8YE | 3 | |
| GENTIANA LUTEA ROOT | ACTIVE MOIETY | S72O3284MS | 3 | |
| LYCOPODIUM CLAVATUM SPORE | ACTIVE MOIETY | C88X29Y479 | 3 | |
| PHOSPHORUS | ACTIVE MOIETY | 27YLU75U4W | 3 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | 3 | |
| PULSATILLA VULGARIS | ACTIVE MOIETY | I76KB35JEV | 3 | |
| SAMBUCUS NIGRA FLOWERING TOP | ACTIVE MOIETY | CT03BSA18U | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- Gastrotone
- Gentiana lutea, Sambucus nigra, Arsenicum album, Kali bichromicum, Lycopodium clavatum, Phosphorus, Pulsatilla Bismuthum carbonicum,
- GENTIANA LUTEA ROOT
- SAMBUCUS NIGRA FLOWERING TOP
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- POTASSIUM DICHROMATE
- DICHROMATE ION
- LYCOPODIUM CLAVATUM SPORE
- PHOSPHORUS
- PULSATILLA VULGARIS
- WATER
- ALCOHOL
- BISMUTH SUBCARBONATE
- BISMUTH CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57520-0355 | 57520-0355-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GENTIANA LUTEA ROOT | S72O3284MS | ACTIB |
| SAMBUCUS NIGRA FLOWERING TOP | CT03BSA18U | ACTIB |
| ARSENIC TRIOXIDE | S7V92P67HO | ACTIB |
| POTASSIUM DICHROMATE | T4423S18FM | ACTIB |
| LYCOPODIUM CLAVATUM SPORE | C88X29Y479 | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| PULSATILLA VULGARIS | I76KB35JEV | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| BISMUTH SUBCARBONATE | M41L2IN55T | ACTIB |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0d4103db-4db9-4ad3-a5e1-f4a1fa131795 | ab855a7e-d1be-4b33-addc-295c94b4304c | 2022-03-29 | Warnings | 0d4103db-4db9-4ad3-a5e1-f4a1fa131795 ab855a7e-d1be-4b33-addc-295c94b4304c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
