Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 76f70259-44b1-467a-bff4-b427ddfe3abd
Route
ORAL
Published
Effective Date 2021-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Berberis Vulgaris Root Bark (3 [hp_X]) Glycyrrhiza Glabra (6 [hp_X]) Arctium Lappa Root (8 [hp_X]) Frangula Purshiana Bark (9 [hp_X]) Trifolium Pratense Flower (10 [hp_X]) Zanthoxylum Americanum Bark (12 [hp_X]) Ascorbic Acid (30 [hp_X]) Methylcobalamin Riboflavin Thiamine Ion Germanium Sesquioxide Cysteine Manganese Cation (2+) Adenosine Triphosphate .alpha.-ketoglutaric Acid Fumaric Acid Magnesium Cation Diethyl Oxalacetate Anemone Pulsatilla Pyruvic Acid Ubidecarenone Calcium Sulfide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-05-05

Description

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Ascorbic Acid 6X, Methylcobalamin 6X, Riboflavinum 6X, Thiaminum Hydrochloricum 6X, Germanium Sesquioxide 8X, Cysteinum 9X, Manganese Gluconate 10X, Adenosinum Triphosphoricum Dinatrum 12X, Alpha-Ketoglutaricum Acidum 12X, Fumaricum Acidum 12X, Magnesia Phosphorica 12X, Natrum Oxalaceticum 12X, Pulsatilla (Vulgaris) 12X, Pyruvic Acid 12X, Ubidecarenonum 12X, Hepar Sulphuris Calcareum 30X.


Medication Information

Description

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Ascorbic Acid 6X, Methylcobalamin 6X, Riboflavinum 6X, Thiaminum Hydrochloricum 6X, Germanium Sesquioxide 8X, Cysteinum 9X, Manganese Gluconate 10X, Adenosinum Triphosphoricum Dinatrum 12X, Alpha-Ketoglutaricum Acidum 12X, Fumaricum Acidum 12X, Magnesia Phosphorica 12X, Natrum Oxalaceticum 12X, Pulsatilla (Vulgaris) 12X, Pyruvic Acid 12X, Ubidecarenonum 12X, Hepar Sulphuris Calcareum 30X.

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 a 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 fatigue, exhaustion, and lowered metabolism.

Active Ingredients:

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Ascorbic Acid 6X, Methylcobalamin 6X, Riboflavinum 6X, Thiaminum Hydrochloricum 6X, Germanium Sesquioxide 8X, Cysteinum 9X, Manganese Gluconate 10X, Adenosinum Triphosphoricum Dinatrum 12X, Alpha-Ketoglutaricum Acidum 12X, Fumaricum Acidum 12X, Magnesia Phosphorica 12X, Natrum Oxalaceticum 12X, Pulsatilla (Vulgaris) 12X, Pyruvic Acid 12X, Ubidecarenonum 12X, Hepar Sulphuris Calcareum 30X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Display Label:

BIOActive Nutritional

METABOLISM

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 a 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 fatigue, exhaustion, and lowered metabolism.

Active Ingredients: (ACTIVE INGREDIENTS:)

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Ascorbic Acid 6X, Methylcobalamin 6X, Riboflavinum 6X, Thiaminum Hydrochloricum 6X, Germanium Sesquioxide 8X, Cysteinum 9X, Manganese Gluconate 10X, Adenosinum Triphosphoricum Dinatrum 12X, Alpha-Ketoglutaricum Acidum 12X, Fumaricum Acidum 12X, Magnesia Phosphorica 12X, Natrum Oxalaceticum 12X, Pulsatilla (Vulgaris) 12X, Pyruvic Acid 12X, Ubidecarenonum 12X, Hepar Sulphuris Calcareum 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Display Label: (PACKAGE DISPLAY LABEL:)

BIOActive Nutritional

METABOLISM

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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