Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 04024663-0b11-438a-a21a-8e86edd8052a
Route
ORAL
Published
Effective Date 2018-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Ligusticum Porteri Root (5 [hp_X]) Myrrh (6 [hp_X]) Nasturtium Officinale (8 [hp_X]) Handroanthus Impetiginosus Bark (12 [hp_X]) Fenugreek Seed Goldenseal Ascorbic Acid Pinus Sylvestris Leafy Twig Sus Scrofa Lymph Sus Scrofa Bone Marrow Sus Scrofa Spleen Sus Scrofa Thymus Calcium Sulfide Phosphoric Acid Silicon Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-07-21

Description

Echinacea (Angustifolia) 3X, Ligusticum Porteri 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Trigonella Foenum-Graecum 3X, Hydrastis Canadensis 5X, Ascorbic Acid 6X, Pinus Sylvestris 6X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Spleen (Suis) 8X, Thymus (Suis) 8X, Hepar Sulphuris Calcareum 12X, Phosphoricum Acidum 12X, Silicea 12X.


Medication Information

Description

Echinacea (Angustifolia) 3X, Ligusticum Porteri 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Trigonella Foenum-Graecum 3X, Hydrastis Canadensis 5X, Ascorbic Acid 6X, Pinus Sylvestris 6X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Spleen (Suis) 8X, Thymus (Suis) 8X, Hepar Sulphuris Calcareum 12X, Phosphoricum Acidum 12X, Silicea 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 a 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 a physician.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

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 painful sore throat, painful earache, and minor bronchial irritation with yellow expectoration.

Active Ingredients:

Echinacea (Angustifolia) 3X, Ligusticum Porteri 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Trigonella Foenum-Graecum 3X, Hydrastis Canadensis 5X, Ascorbic Acid 6X, Pinus Sylvestris 6X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Spleen (Suis) 8X, Thymus (Suis) 8X, Hepar Sulphuris Calcareum 12X, Phosphoricum Acidum 12X, Silicea 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

IMMUNO FORTIFIER

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.

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 a physician.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

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 painful sore throat, painful earache, and minor bronchial irritation with yellow expectoration.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea (Angustifolia) 3X, Ligusticum Porteri 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Trigonella Foenum-Graecum 3X, Hydrastis Canadensis 5X, Ascorbic Acid 6X, Pinus Sylvestris 6X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Spleen (Suis) 8X, Thymus (Suis) 8X, Hepar Sulphuris Calcareum 12X, Phosphoricum Acidum 12X, Silicea 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

IMMUNO FORTIFIER

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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