Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID faa4a678-321a-4982-a5d4-01b713e6862d
Route
ORAL
Published
Effective Date 2017-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Baptisia Tinctoria (3 [hp_X]) Echinacea Angustifolia (4 [hp_X]) Handroanthus Impetiginosus Bark (5 [hp_X]) Trifolium Pratense Flower (6 [hp_X]) Arnica Montana (8 [hp_X]) Calendula Officinalis Flowering Top (12 [hp_X]) Chelidonium Majus (30 [hp_X]) Culver's Root (30 [hp_C]) Ligusticum Porteri Root Lomatium Dissectum Root Myrrh Nasturtium Officinale Phytolacca Americana Root Taraxacum Officinale Fenugreek Seed Urtica Dioica Goldenseal Astragalus Propinquus Root Propolis Wax Sus Scrofa Adrenal Gland Sus Scrofa Thymus Arsenic Cation (3+) Atropa Belladonna Chamomile Lycopodium Clavatum Spore Toxicodendron Pubescens Leaf Silicon Dioxide Thuja Occidentalis Leafy Twig Antimony Trisulfide Bordetella Pertussis Tetanus Toxin Ethylmercurithiosalicylic Acid
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-07-20

Description

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Tabebuia Impetiginosa 3X, Trifolium Pratense 3X, Arnica Montana 4X, Calendula Officinalis 4X, Chelidonium Majus 4X, Leptandra Virginica 4X, Ligusticum Porteri 4X, Lomatium Dissectum 4X, Myrrha 4X, Nasturtium Aquaticum 4X, Phytolacca Decandra 4X, Taraxacum Officinale 4X, Trigonella Foenum-Graecum 4X, Urtica Dioica 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Suis 8X, Thymus (Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Chamomilla 12X, Lycopodium Clavatum 12X, Rhus Tox 12X, Silicea 30X, Thuja Occidentalis 30X, Antimonium Crudum 30X, 200X, Pertussinum 30C, Tetanus Toxin 30X, Thimerosal 30C.


Medication Information

Description

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Tabebuia Impetiginosa 3X, Trifolium Pratense 3X, Arnica Montana 4X, Calendula Officinalis 4X, Chelidonium Majus 4X, Leptandra Virginica 4X, Ligusticum Porteri 4X, Lomatium Dissectum 4X, Myrrha 4X, Nasturtium Aquaticum 4X, Phytolacca Decandra 4X, Taraxacum Officinale 4X, Trigonella Foenum-Graecum 4X, Urtica Dioica 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Suis 8X, Thymus (Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Chamomilla 12X, Lycopodium Clavatum 12X, Rhus Tox 12X, Silicea 30X, Thuja Occidentalis 30X, Antimonium Crudum 30X, 200X, Pertussinum 30C, Tetanus Toxin 30X, Thimerosal 30C.

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.

Questions:

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 skin irritation, dry cough, eczema, and fever.

Active Ingredients:

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Tabebuia Impetiginosa 3X, Trifolium Pratense 3X, Arnica Montana 4X, Calendula Officinalis 4X, Chelidonium Majus 4X, Leptandra Virginica 4X, Ligusticum Porteri 4X, Lomatium Dissectum 4X, Myrrha 4X, Nasturtium Aquaticum 4X, Phytolacca Decandra 4X, Taraxacum Officinale 4X, Trigonella Foenum-Graecum 4X, Urtica Dioica 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Suis 8X, Thymus (Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Chamomilla 12X, Lycopodium Clavatum 12X, Rhus Tox 12X, Silicea 30X, Thuja Occidentalis 30X, Antimonium Crudum 30X, 200X, Pertussinum 30C, Tetanus Toxin 30X, Thimerosal 30C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

VAX

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.


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.

Questions: (QUESTIONS:)

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 skin irritation, dry cough, eczema, and fever.

Active Ingredients: (ACTIVE INGREDIENTS:)

Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Tabebuia Impetiginosa 3X, Trifolium Pratense 3X, Arnica Montana 4X, Calendula Officinalis 4X, Chelidonium Majus 4X, Leptandra Virginica 4X, Ligusticum Porteri 4X, Lomatium Dissectum 4X, Myrrha 4X, Nasturtium Aquaticum 4X, Phytolacca Decandra 4X, Taraxacum Officinale 4X, Trigonella Foenum-Graecum 4X, Urtica Dioica 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Suis 8X, Thymus (Suis) 8X, Arsenicum Album 12X, Belladonna 12X, Chamomilla 12X, Lycopodium Clavatum 12X, Rhus Tox 12X, Silicea 30X, Thuja Occidentalis 30X, Antimonium Crudum 30X, 200X, Pertussinum 30C, Tetanus Toxin 30X, Thimerosal 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

VAX

HOMEOPATHIC

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

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