Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID ddfad5cd-c928-42c0-9562-9feebb73a2cb
Route
ORAL
Published
Effective Date 2018-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Nasturtium Officinale (4 [hp_X]) Phytolacca Americana Root (5 [hp_X]) Goldenseal (12 [hp_X]) Apis Mellifera Atropa Belladonna Ferrosoferric Phosphate Nitric Acid Nerium Oleander Leaf Silicon Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-03-06 Until 2029-11-08

Description

Echinacea (Angustifolia) 3X, Nasturtium Aquaticum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Apis Mellifica 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Nitricum Acidum 12X, Oleander 12X, Silicea 12X.


Medication Information

Description

Echinacea (Angustifolia) 3X, Nasturtium Aquaticum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Apis Mellifica 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Nitricum Acidum 12X, Oleander 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 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 swollen throat, minor throbbing pain deep in the ear; joints swollen and hot; chills and fever with nausea.

Active Ingredients:

Echinacea (Angustifolia) 3X, Nasturtium Aquaticum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Apis Mellifica 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Nitricum Acidum 12X, Oleander 12X, Silicea 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

INFLAMMATION I

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 swollen throat, minor throbbing pain deep in the ear; joints swollen and hot; chills and fever with nausea.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea (Angustifolia) 3X, Nasturtium Aquaticum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Apis Mellifica 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Nitricum Acidum 12X, Oleander 12X, Silicea 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

INFLAMMATION I

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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