Drug Facts:

Drug Facts:
SPL v5
SPL
SPL Set ID 562cc0df-a340-4573-88b1-0d4119ec9766
Route
ORAL
Published
Effective Date 2015-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-02-17

Description

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


Medication Information

Warnings and Precautions

WARNINGS:  If pregnant or breast-feeding, ask a health care professional before use.

Keep our 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.

Dosage and Administration

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

Description

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

Section 51727-6

Inactive Ingredients:  Demineralized Water, 25% Ethanol



Section 51945-4

BioActive Homeopathic

FNG II

1 FL OZ (30 ML)

Section 53413-1

Distributed By:

BioActive Nutritional

Melbourne, FL 32935

For Nutritional Information Write:

BioActive Nutritional, Inc.

1803 N Wickham Rd.

Melbourne, FL 32935

Section 55105-1

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

Section 55106-9

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



Indications & Usage Section:

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

Keep Out of Reach of Children:

Keep our of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

WARNINGS:  If pregnant or breast-feeding, ask a health care professional before use.

Keep our 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.

Section 51727-6 (51727-6)

Inactive Ingredients:  Demineralized Water, 25% Ethanol



Section 51945-4 (51945-4)

BioActive Homeopathic

FNG II

1 FL OZ (30 ML)

Section 53413-1 (53413-1)

Distributed By:

BioActive Nutritional

Melbourne, FL 32935

For Nutritional Information Write:

BioActive Nutritional, Inc.

1803 N Wickham Rd.

Melbourne, FL 32935

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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



Indications & Usage Section: (INDICATIONS & USAGE SECTION:)

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

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Keep our 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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