Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID d15cbfe9-051d-4aeb-a0f3-105bef7796bc
Route
ORAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Lomatium Dissectum Root (5 [hp_X]) Nasturtium Officinale (6 [hp_X]) Tabebuia Impetiginosa Bark (8 [hp_X]) Goldenseal (12 [hp_X]) Iodine (30 [hp_X]) Epinephrine Silver Sus Scrofa Thymus Sus Scrofa Thyroid Phosphoric Acid Candida Albicans Lycopodium Clavatum Spore Anemone Pulsatilla Sepia Officinalis Juice
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-12-20

Description

Adrenalinum 8X, Argentum Metallicum 8X, Candida Albicans 12X, 30X, Echinacea 3X, Hydrastis Canadensis 5X, Iodium 6X, Lomatium Dissectum 3X, Lycopodium Clavatum 30X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Thymus 8X, Thyroidinum 8X, Phosphoricum Acidum 12X, Pulsatilla 30X, Sepia 30X.

Purpose

Adrenalinum – lung congestion,** Argentum Metallicum – cold symptoms,** Candida Albicans - indigestion,** Echinacea – sore throat,** Hydrastis Canadensis – abdominal gas,** Iodium - fatigue,** Lomatium Dissectum – mucus congestion,** Lycopodium Clavatum - bloating,** Nasturtium Aquaticum - swelling,** Tabebuia Impetiginosa – occasional diarrhea,** Thymus - fatigue,** Thyroidinum – abdominal pain,** Phosphoricum Acidum – dry mouth,** Pulsatilla – abdominal cramps,** Sepia – constipation** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Adrenalinum – lung congestion,** Argentum Metallicum – cold symptoms,** Candida Albicans - indigestion,** Echinacea – sore throat,** Hydrastis Canadensis – abdominal gas,** Iodium - fatigue,** Lomatium Dissectum – mucus congestion,** Lycopodium Clavatum - bloating,** Nasturtium Aquaticum - swelling,** Tabebuia Impetiginosa – occasional diarrhea,** Thymus - fatigue,** Thyroidinum – abdominal pain,** Phosphoricum Acidum – dry mouth,** Pulsatilla – abdominal cramps,** Sepia – constipation** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Adrenalinum 8X, Argentum Metallicum 8X, Candida Albicans 12X, 30X, Echinacea 3X, Hydrastis Canadensis 5X, Iodium 6X, Lomatium Dissectum 3X, Lycopodium Clavatum 30X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Thymus 8X, Thyroidinum 8X, Phosphoricum Acidum 12X, Pulsatilla 30X, Sepia 30X.

Uses:

For temporary relief of bloating of the stomach, flatulence, and allergic rhinitis.**

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

Purpose:

Adrenalinum – lung congestion,** Argentum Metallicum – cold symptoms,** Candida Albicans - indigestion,** Echinacea – sore throat,** Hydrastis Canadensis – abdominal gas,** Iodium - fatigue,** Lomatium Dissectum – mucus congestion,** Lycopodium Clavatum - bloating,** Nasturtium Aquaticum - swelling,** Tabebuia Impetiginosa – occasional diarrhea,** Thymus - fatigue,** Thyroidinum – abdominal pain,** Phosphoricum Acidum – dry mouth,** Pulsatilla – abdominal cramps,** Sepia – constipation**

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

Warnings:

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.

Consult  physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

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.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BioActive Nutritional

FNG II

HOMEOPATHIC

1 fl. oz. (30 mL)

active Ingredients:

Adrenalinum 8X, Argentum Metallicum 8X, Candida Albicans 12X, 30X, Echinacea 3X, Hydrastis Canadensis 5X, Iodium 6X, Lomatium Dissectum 3X, Lycopodium Clavatum 30X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Thymus 8X, Thyroidinum 8X, Phosphoricum Acidum 12X, Pulsatilla 30X, Sepia 30X.

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 bloating of the stomach, flatulence, and allergic rhinitis.**

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

Purpose: (PURPOSE:)

Adrenalinum – lung congestion,** Argentum Metallicum – cold symptoms,** Candida Albicans - indigestion,** Echinacea – sore throat,** Hydrastis Canadensis – abdominal gas,** Iodium - fatigue,** Lomatium Dissectum – mucus congestion,** Lycopodium Clavatum - bloating,** Nasturtium Aquaticum - swelling,** Tabebuia Impetiginosa – occasional diarrhea,** Thymus - fatigue,** Thyroidinum – abdominal pain,** Phosphoricum Acidum – dry mouth,** Pulsatilla – abdominal cramps,** Sepia – constipation**

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

Warnings: (WARNINGS:)

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.

Consult  physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BioActive Nutritional

FNG II

HOMEOPATHIC

1 fl. oz. (30 mL)

active Ingredients: (ACTIVE INGREDIENTS:)

Adrenalinum 8X, Argentum Metallicum 8X, Candida Albicans 12X, 30X, Echinacea 3X, Hydrastis Canadensis 5X, Iodium 6X, Lomatium Dissectum 3X, Lycopodium Clavatum 30X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Thymus 8X, Thyroidinum 8X, Phosphoricum Acidum 12X, Pulsatilla 30X, Sepia 30X.

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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