Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 7920e8f6-be48-4402-9085-9673779db5a2
Route
ORAL
Published
Effective Date 2018-08-02
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
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-08-02 Until 2028-07-28

Description

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X.


Medication Information

Description

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 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.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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 swellings with heat and inflammation, and sore throat.

Active Ingredients:

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

DRAINAGE

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.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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 swellings with heat and inflammation, and sore throat.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea (Angustifolia) 3X, Trifolium Pratense 3X, Phytolacca Decandra 4X, Calcarea Iodata 12X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Sulphur Iodatum 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

DRAINAGE

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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