drug facts:

drug facts:
SPL v2
SPL
SPL Set ID 2d15e40e-86b8-425d-ad20-100ff3e21b55
Route
oral
Published
Effective Date 2018-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
gentiana lutea root (3 [hp_X]) sambucus nigra flowering top (12 [hp_X]) arsenic cation (3+) (15 [hp_X]) dichromate ion lycopodium clavatum spore phosphorus anemone pulsatilla bismuth cation
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic completed Since 2018-05-08 Until 2025-11-03

Description

Gentiana Lutea 3X, Sambucus Nigra 3X, Arsenicum Album 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum Subnitricum 15X.


Medication Information

Description

Gentiana Lutea 3X, Sambucus Nigra 3X, Arsenicum Album 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum Subnitricum 15X.

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

Directions:

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.

Indications:

May temporarily relieve indigestion, nausea, retching, vomiting after eating or drinking, and minor burning in the stomach. **

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

Gentiana Lutea 3X, Sambucus Nigra 3X, Arsenicum Album 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum Subnitricum 15X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GASTROTONE

1 fl. oz. (30 ml)

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.


Structured Label Content

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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

Directions: (DIRECTIONS:)

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.

Indications: (INDICATIONS:)

May temporarily relieve indigestion, nausea, retching, vomiting after eating or drinking, and minor burning in the stomach. **

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

Gentiana Lutea 3X, Sambucus Nigra 3X, Arsenicum Album 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Phosphorus 12X, Pulsatilla 12X, Bismuthum Subnitricum 15X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GASTROTONE

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)