Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID f8846fb1-92e5-4f8e-b3b3-bc620df90a62
Route
ORAL
Published
Effective Date 2021-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triticum Aestivum Whole (1 [hp_X]) Alfalfa (3 [hp_X]) Arnica Montana (6 [hp_X]) Asclepias Tuberosa Root (8 [hp_X]) Matricaria Chamomilla (9 [hp_X]) Echinacea Angustifolia (12 [hp_X]) Eucalyptus Globulus Leaf Fucus Vesiculosus Hordeum Vulgare Top Iodine Nasturtium Officinale Plantago Major Daikon Trifolium Pratense Flower Trigonella Foenum-graecum Whole Symphytum Officinale Whole Sus Scrofa Lung Oryza Sativa Whole Silicon Dioxide Acetone Tripolyphosphate Ion Propylene Glycol Benzene Ammonium Cation Lauryl Sulfate Turpentine Oil Arsenic Cation (3+) Chloride Ion Nitric Acid Oenanthe Aquatica Fruit Phosphoric Acid Phosphorus Pulsatilla Pratensis Whole Toxicodendron Pubescens Leaf
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-10-02

Description

Triticum Aestivum 1X, 3X Alfalfa 3X, Arnica Montana 3X, Asclepias Tuberosa 3X, Chamomilla 3X, Echinacea (Angustifolia) 3X, Eucalyptus Globulus 3X, Fucus Vesiculosus 3X, Hordeum Vulgare 3X, Iodium 3X, Nasturtium Aquaticum 3X, Plantago Major 3X, Raphanus Sativus 3X, Trifolium Pratense 3X, Trigonella Foenum-Graecum 3X, Symphytum Officinale 6X, Lung (Suis) 8X, Oryza Sativa 8X, Silicea 8X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Arsenicum Album 12X, Natrum Muriaticum 12X, Nitricum Acidum 12X, Phellandrium Aquaticum 12X, Phosphoricum Acidum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X.


Medication Information

Description

Triticum Aestivum 1X, 3X Alfalfa 3X, Arnica Montana 3X, Asclepias Tuberosa 3X, Chamomilla 3X, Echinacea (Angustifolia) 3X, Eucalyptus Globulus 3X, Fucus Vesiculosus 3X, Hordeum Vulgare 3X, Iodium 3X, Nasturtium Aquaticum 3X, Plantago Major 3X, Raphanus Sativus 3X, Trifolium Pratense 3X, Trigonella Foenum-Graecum 3X, Symphytum Officinale 6X, Lung (Suis) 8X, Oryza Sativa 8X, Silicea 8X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Arsenicum Album 12X, Natrum Muriaticum 12X, Nitricum Acidum 12X, Phellandrium Aquaticum 12X, Phosphoricum Acidum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X.

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

*For a complete list of Environmental Isodes contact BioActive Nutritional, Inc.

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 cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.

Active Ingredients:

Triticum Aestivum 1X, 3X Alfalfa 3X, Arnica Montana 3X, Asclepias Tuberosa 3X, Chamomilla 3X, Echinacea (Angustifolia) 3X, Eucalyptus Globulus 3X, Fucus Vesiculosus 3X, Hordeum Vulgare 3X, Iodium 3X, Nasturtium Aquaticum 3X, Plantago Major 3X, Raphanus Sativus 3X, Trifolium Pratense 3X, Trigonella Foenum-Graecum 3X, Symphytum Officinale 6X, Lung (Suis) 8X, Oryza Sativa 8X, Silicea 8X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Arsenicum Album 12X, Natrum Muriaticum 12X, Nitricum Acidum 12X, Phellandrium Aquaticum 12X, Phosphoricum Acidum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

PNEUMOTOX

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

*For a complete list of Environmental Isodes contact BioActive Nutritional, Inc.

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 cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.

Active Ingredients: (ACTIVE INGREDIENTS:)

Triticum Aestivum 1X, 3X Alfalfa 3X, Arnica Montana 3X, Asclepias Tuberosa 3X, Chamomilla 3X, Echinacea (Angustifolia) 3X, Eucalyptus Globulus 3X, Fucus Vesiculosus 3X, Hordeum Vulgare 3X, Iodium 3X, Nasturtium Aquaticum 3X, Plantago Major 3X, Raphanus Sativus 3X, Trifolium Pratense 3X, Trigonella Foenum-Graecum 3X, Symphytum Officinale 6X, Lung (Suis) 8X, Oryza Sativa 8X, Silicea 8X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Arsenicum Album 12X, Natrum Muriaticum 12X, Nitricum Acidum 12X, Phellandrium Aquaticum 12X, Phosphoricum Acidum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

PNEUMOTOX

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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