Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID df277f21-9e60-4c64-928a-b1d925103282
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Trifolium Pratense Flower (4 [hp_X]) Phytolacca Americana Root (12 [hp_X]) Calcium Cation Potassium Cation Nitric Acid Phosphoric Acid Sulfur Iodide Dimethicone
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-10-07

Description

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Chloricum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X, Silicone (Dimethicone)12X, 30X, 200X.


Medication Information

Description

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Chloricum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X, Silicone (Dimethicone)12X, 30X, 200X.

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 symptoms related to headaches, cold hands and feet, and spasms.

Active Ingredients:

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Chloricum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X, Silicone (Dimethicone)12X, 30X, 200X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BioActive Homeopathic

SILICEA COMPLEX II

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children:

Keep out of reach of children. In case of overdose, get medical attention 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 symptoms related to headaches, cold hands and feet, and spasms.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Chloricum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X, Silicone (Dimethicone)12X, 30X, 200X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BioActive Homeopathic

SILICEA COMPLEX II

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 attention or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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