Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID d235f51f-c773-4dd1-84f4-1ee5c3365d13
Route
ORAL
Published
Effective Date 2025-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Leonurus Cardiaca (3 [hp_X]) Amanita Muscaria Fruiting Body (12 [hp_X]) Arsenic Cation (3+) Anamirta Cocculus Seed Conium Maculatum Flowering Top Kerosene Phosphorus Anemone Pulsatilla Tobacco Leaf Theridion Curassavicum
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-06-01

Description

Agaricus Muscarius 12X, Arsenicum Album 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Leonurus Cardiaca 3X, Petroleum 12X, Phosphorus 12X, Pulsatilla 12X, Tabacum 12X, Theridion 12X.

Purpose

Agaricus Muscarius – stomach discomfort,** Arsenicum Album - nausea,** Cocculus Indicus – motion sickness,** Conium Maculatum - dizziness,** Leonurus Cardiaca - vomiting,** Petroleum - nausea,** Phosphorus – motion sickness,** Pulsatilla - diarrhea,** Tabacum - faintness,** Theridion – vertigo** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Agaricus Muscarius – stomach discomfort,** Arsenicum Album - nausea,** Cocculus Indicus – motion sickness,** Conium Maculatum - dizziness,** Leonurus Cardiaca - vomiting,** Petroleum - nausea,** Phosphorus – motion sickness,** Pulsatilla - diarrhea,** Tabacum - faintness,** Theridion – vertigo** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Agaricus Muscarius 12X, Arsenicum Album 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Leonurus Cardiaca 3X, Petroleum 12X, Phosphorus 12X, Pulsatilla 12X, Tabacum 12X, Theridion 12X.

Uses:

For temporary relief of motion sickness with nausea on least motion, dizziness with nausea when riding or sitting up, dizziness when lying down and turning over in bed.

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

Purpose:

Agaricus Muscarius – stomach discomfort,** Arsenicum Album - nausea,** Cocculus Indicus – motion sickness,** Conium Maculatum - dizziness,** Leonurus Cardiaca - vomiting,** Petroleum - nausea,** Phosphorus – motion sickness,** Pulsatilla - diarrhea,** Tabacum - faintness,** Theridion – vertigo**

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

Warnings:

If pregnant or breast-feeding, ask a health care 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:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions:

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients:

Agaricus Muscarius 12X, Arsenicum Album 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Leonurus Cardiaca 3X, Petroleum 12X, Phosphorus 12X, Pulsatilla 12X, Tabacum 12X, Theridion 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol 

Package Label Display:

BIOActive Nutritional

BALANCEFORCE V

HOMEOPATHIC

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:)

For temporary relief of motion sickness with nausea on least motion, dizziness with nausea when riding or sitting up, dizziness when lying down and turning over in bed.

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

Purpose: (PURPOSE:)

Agaricus Muscarius – stomach discomfort,** Arsenicum Album - nausea,** Cocculus Indicus – motion sickness,** Conium Maculatum - dizziness,** Leonurus Cardiaca - vomiting,** Petroleum - nausea,** Phosphorus – motion sickness,** Pulsatilla - diarrhea,** Tabacum - faintness,** Theridion – vertigo**

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

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health care 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:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions: (DIRECTIONS:)

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Agaricus Muscarius 12X, Arsenicum Album 12X, Cocculus Indicus 12X, Conium Maculatum 12X, Leonurus Cardiaca 3X, Petroleum 12X, Phosphorus 12X, Pulsatilla 12X, Tabacum 12X, Theridion 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol 

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

BALANCEFORCE V

HOMEOPATHIC

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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