Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID e9d6b64f-9b20-422c-91f6-c26def4d53d0
Route
ORAL
Published
Effective Date 2024-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chelidonium Majus (3 [hp_X]) Echinacea Angustifolia (12 [hp_X]) Gentiana Lutea Root Arsenic Cation (3+) Activated Charcoal Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Phosphorus Pulsatilla Pratensis Whole
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-04-22

Description

(in each drop)  Arsenicum Album 12X 16.62%, Carbo Vegetabilis 12X 16.62%, Lycopodium Clavatum 12X 16.62%, Nux Vomica 12X 16.62%, Phosphorus 12X 16.62%, Pulsatilla 12X 16.62%, Chelidonium Majus 3X 0.10%, Echinacea 3X 0.10%, Gentiana Lutea 3X 0.10%.

Purpose

Arsenicum Album – shortness of breath,** Carbo Vegetabilis - indigestion,** Lycopodium Clavatum - bloating,** Nux Vomica - nausea,** Phosphorus - itching,** Pulsatilla - hives,** Chelidonium Majus - headache,** Echinacea – nasal congestion,** Gentiana Lutea – diarrhea** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Arsenicum Album – shortness of breath,** Carbo Vegetabilis - indigestion,** Lycopodium Clavatum - bloating,** Nux Vomica - nausea,** Phosphorus - itching,** Pulsatilla - hives,** Chelidonium Majus - headache,** Echinacea – nasal congestion,** Gentiana Lutea – diarrhea** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop)  Arsenicum Album 12X 16.62%, Carbo Vegetabilis 12X 16.62%, Lycopodium Clavatum 12X 16.62%, Nux Vomica 12X 16.62%, Phosphorus 12X 16.62%, Pulsatilla 12X 16.62%, Chelidonium Majus 3X 0.10%, Echinacea 3X 0.10%, Gentiana Lutea 3X 0.10%.

Uses:

May temporarily relieve digestive symptoms, such as:

• indigestion with flatulence and bloating • loss of weight, associated with problem foods.**

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

Purpose:

Arsenicum Album – shortness of breath,** Carbo Vegetabilis - indigestion,** Lycopodium Clavatum - bloating,** Nux Vomica - nausea,** Phosphorus - itching,** Pulsatilla - hives,** Chelidonium Majus - headache,** Echinacea – nasal congestion,** Gentiana Lutea – diarrhea**

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

Warnings:

Stop use and ask a doctor if symptoms persist for more than 2 days.

If pregnant or breastfeeding, 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.

• Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each drop) Arsenicum Album 12X 16.62%, Carbo Vegetabilis 12X 16.62%, Lycopodium Clavatum 12X 16.62%, Nux Vomica 12X 16.62%, Phosphorus 12X 16.62%, Pulsatilla 12X 16.62%, Chelidonium Majus 3X 0.10%, Echinacea 3X 0.10%, Gentiana Lutea 3X 0.10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HISTASTAT FOOD

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

May temporarily relieve digestive symptoms, such as:

• indigestion with flatulence and bloating • loss of weight, associated with problem foods.**

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

Purpose: (PURPOSE:)

Arsenicum Album – shortness of breath,** Carbo Vegetabilis - indigestion,** Lycopodium Clavatum - bloating,** Nux Vomica - nausea,** Phosphorus - itching,** Pulsatilla - hives,** Chelidonium Majus - headache,** Echinacea – nasal congestion,** Gentiana Lutea – diarrhea**

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

Warnings: (WARNINGS:)

Stop use and ask a doctor if symptoms persist for more than 2 days.

If pregnant or breastfeeding, 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.

• Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Arsenicum Album 12X 16.62%, Carbo Vegetabilis 12X 16.62%, Lycopodium Clavatum 12X 16.62%, Nux Vomica 12X 16.62%, Phosphorus 12X 16.62%, Pulsatilla 12X 16.62%, Chelidonium Majus 3X 0.10%, Echinacea 3X 0.10%, Gentiana Lutea 3X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HISTASTAT FOOD

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.


Advanced Ingredient Data


Raw Label Data

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