Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID f4395bb7-c186-4e4f-a7cd-a7f3db46091a
Route
ORAL
Published
Effective Date 2021-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Purpurea (1 [hp_X]) Goldenseal (5 [hp_X]) Eupatorium Perfoliatum Flowering Top (6 [hp_X]) Verbascum Thapsus (8 [hp_X]) Ailanthus Altissima Flowering Twig (12 [hp_X]) Onion (16 [hp_X]) Ambrosia Artemisiifolia Gold Cation (3+) Camphor (natural) Ipecac Dichromate Ion Solidago Virgaurea Flowering Top Poa Pratensis Pollen Dactylis Glomerata Pollen Cynodon Dactylon Whole Sorghum Halepense Pollen Lolium Perenne Pollen Anthoxanthum Odoratum Paspalum Notatum Pollen Phleum Pratense Top Ulmus Americana Pollen Platanus X Acerifolia Pollen Fraxinus Excelsior Pollen Fagus Sylvatica Pollen Salix X Fragilis Pollen Acer Negundo Pollen Alnus Rubra Pollen Juniperus Virginiana Pollen Acer Saccharum Pollen Corylus Avellana Pollen Populus Alba Pollen Betula Pendula Pollen Quercus Robur Pollen Carya Glabra Pollen
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-08-03

Description

Echinacea Purpurea MT, 3X, Hydrastis Canadensis 5X, Eupatorium Perfoliatum 6X, 12X, Verbascum Thapsus 8X, Ailanthus Glandulosus 12X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Aurum Muriaticum 12X, Camphora 12X, Ipecacuanha 12X, Kali Bichromicum 12X, Solidago Virgaurea 12X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X, American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 30X.


Medication Information

Description

Echinacea Purpurea MT, 3X, Hydrastis Canadensis 5X, Eupatorium Perfoliatum 6X, 12X, Verbascum Thapsus 8X, Ailanthus Glandulosus 12X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Aurum Muriaticum 12X, Camphora 12X, Ipecacuanha 12X, Kali Bichromicum 12X, Solidago Virgaurea 12X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X, American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 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 coryza, sneezing, water discharge. Stuffed up feeling of nose and head. Eyes red with much burning. Hoarseness and cough with soreness in the chest.

Active Ingredients:

Echinacea Purpurea MT, 3X, Hydrastis Canadensis 5X, Eupatorium Perfoliatum 6X, 12X, Verbascum Thapsus 8X, Ailanthus Glandulosus 12X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Aurum Muriaticum 12X, Camphora 12X, Ipecacuanha 12X, Kali Bichromicum 12X, Solidago Virgaurea 12X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X, American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 30X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

HAYFEVER TONIC

HOMEOPATHIC

2 FL OZ (60 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 coryza, sneezing, water discharge. Stuffed up feeling of nose and head. Eyes red with much burning. Hoarseness and cough with soreness in the chest.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea Purpurea MT, 3X, Hydrastis Canadensis 5X, Eupatorium Perfoliatum 6X, 12X, Verbascum Thapsus 8X, Ailanthus Glandulosus 12X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Aurum Muriaticum 12X, Camphora 12X, Ipecacuanha 12X, Kali Bichromicum 12X, Solidago Virgaurea 12X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X, American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

HAYFEVER TONIC

HOMEOPATHIC

2 FL OZ (60 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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