Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID c3dfd199-ac9b-450f-9459-721e100fa56a
Route
ORAL
Published
Effective Date 2021-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Lomatium Dissectum Root (4 [hp_X]) Nasturtium Officinale (5 [hp_X]) Handroanthus Impetiginosus Bark (6 [hp_X]) Marsdenia Condurango Bark (8 [hp_X]) Ginkgo (12 [hp_X]) Ligusticum Porteri Root (30 [hp_X]) Goldenseal (30 [hp_C]) Astragalus Propinquus Root Propolis Wax Bos Taurus Adrenal Gland Bos Taurus Thymus Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Phosphoric Acid Phytolacca Americana Root Sepia Officinalis Juice Alternaria Alternata Aspergillus Niger Var. Niger Candida Albicans Candida Parapsilosis Saccharomyces Cerevisiae Mucor Racemosus Rhizopus Stolonifer
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2021-06-01 Until 2028-08-22

Description

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Condurango 4X, Ginkgo Biloba 4X, Ligusticum Porteri 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Bovine 8X, Thymus (Bovine) 8X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 12X, Sepia 12X, Alternaria Tenuis Nees 30X, 200X, Aspergillus Niger 30X, 200X, Candida Albicans 30X, 200X, Candida Parapsilosis 30X, 200X, Torula Cerevisiae 30X, 200X, Mucor Racemosus 30X, 200X, Rhizopus Nigricans 30C, 200C.


Medication Information

Description

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Condurango 4X, Ginkgo Biloba 4X, Ligusticum Porteri 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Bovine 8X, Thymus (Bovine) 8X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 12X, Sepia 12X, Alternaria Tenuis Nees 30X, 200X, Aspergillus Niger 30X, 200X, Candida Albicans 30X, 200X, Candida Parapsilosis 30X, 200X, Torula Cerevisiae 30X, 200X, Mucor Racemosus 30X, 200X, Rhizopus Nigricans 30C, 200C.

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 cool, dry place.

Quesitons:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of bloating of the bowels, heartburn, and intolerance of dried fruits.

Active Ingredients:

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Condurango 4X, Ginkgo Biloba 4X, Ligusticum Porteri 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Bovine 8X, Thymus (Bovine) 8X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 12X, Sepia 12X, Alternaria Tenuis Nees 30X, 200X, Aspergillus Niger 30X, 200X, Candida Albicans 30X, 200X, Candida Parapsilosis 30X, 200X, Torula Cerevisiae 30X, 200X, Mucor Racemosus 30X, 200X, Rhizopus Nigricans 30C, 200C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

FNG I

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

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 cool, dry place.

Quesitons: (QUESITONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of bloating of the bowels, heartburn, and intolerance of dried fruits.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Condurango 4X, Ginkgo Biloba 4X, Ligusticum Porteri 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Bovine 8X, Thymus (Bovine) 8X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 12X, Sepia 12X, Alternaria Tenuis Nees 30X, 200X, Aspergillus Niger 30X, 200X, Candida Albicans 30X, 200X, Candida Parapsilosis 30X, 200X, Torula Cerevisiae 30X, 200X, Mucor Racemosus 30X, 200X, Rhizopus Nigricans 30C, 200C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

FNG I

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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