Allergena - Texas Cedar Fever Spray

Allergena - Texas Cedar Fever Spray
SPL v2
SPL
SPL Set ID 779ae138-ae3c-43cc-aa20-d006c8a201a4
Route
ORAL
Published
Effective Date 2020-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea, Unspecified (3 [hp_X]) Baptisia Tinctoria Root (30 [hp_X]) Goldenseal Myrrh Nasturtium Officinale Phytolacca Americana Root Fenugreek Leaf Acacia Pollen Alnus Incana Subsp. Rugosa Pollen Fraxinus Velutina Pollen Fraxinus Pennsylvanica Pollen Fraxinus Americana Pollen Fagus Grandifolia Pollen Betula Papyrifera Pollen Betula Nigra Pollen Betula Lenta Pollen Acer Negundo Pollen Juniperus Virginiana Pollen Populus Deltoides Pollen Populus Deltoides Subsp. Monilifera Pollen Cupressus Arizonica Pollen Taxodium Distichum Pollen Ulmus Americana Pollen Ulmus Pumila Pollen Ulmus Crassifolia Pollen Baccharis Halimifolia Pollen Celtis Occidentalis Pollen Carya Cordiformis Pollen Carya Glabra Pollen Carya Ovata Pollen Carya Alba Pollen Juniperus Ashei Pollen Ligustrum Vulgare Pollen Acer Rubrum Pollen Acer Saccharinum Pollen Prosopis Juliflora Pollen Broussonetia Papyrifera Pollen Morus Rubra Pollen Morus Alba Pollen Quercus Velutina Pollen Quercus Macrocarpa Pollen Quercus Stellata Pollen Quercus Rubra Pollen Quercus Alba Pollen Carya Illinoinensis Pollen Pinus Nigra Pollen Pinus Taeda Pollen Pinus Sylvestris Pollen Populus Nigra Pollen Populus Alba Pollen Picea Pungens Pollen Liquidambar Styraciflua Pollen Platanus Occidentalis Pollen Ailanthus Altissima Pollen Juglans Nigra Pollen Salix Nigra Pollen Amphiachyris Dracunculoides Pollen Amaranthus Palmeri Pollen Xanthium Strumarium Pollen Bassia Scoparia Pollen Solidago Canadensis Pollen Chenopodium Album Pollen Chenopodium Ambrosioides Pollen Cyclachaena Xanthifolia Pollen Iva Annua Pollen Iva Angustifolia Pollen Artemisia Vulgaris Pollen Urtica Dioica Pollen Amaranthus Retroflexus Pollen Amaranthus Spinosus Pollen Plantago Lanceolata Pollen Ambrosia Trifida Pollen Ambrosia Artemisiifolia Pollen Ambrosia Psilostachya Pollen Salsola Tragus Pollen Artemisia Tridentata Pollen Artemisia Frigida Pollen Rumex Obtusifolius Pollen Rumex Crispus Pollen Amaranthus Tuberculatus Pollen Atriplex Canescens Pollen Artemisia Annua Pollen Cynodon Dactylon Pollen Poa Annua Pollen Bromus Inermis Pollen Zea Mays Pollen Sorghum Halepense Pollen Koeleria Macrantha Pollen Festuca Pratensis Pollen Arrhenatherum Elatius Pollen Avena Sativa Pollen Dactylis Glomerata Pollen Elymus Repens Pollen Agrostis Gigantea Pollen Phalaris Arundinacea Pollen Lolium Multiflorum Pollen Lolium Perenne Pollen Sorghum Bicolor Pollen Sorghum X Drummondii Pollen Pascopyrum Smithii Pollen Phleum Pratense Pollen Triticum Aestivum Pollen
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-03-09

Description

Active Ingredients: Antigens 6X,12X,30X:  **Texas Grasses, **Texas Trees,**Texas Weeds, Echinacea 3X HPUS; Herbal  Drainage Remedies 3X:  Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum.


Medication Information

Warnings and Precautions

Warnings:

  • Use Only as directed.
  • Stop use and ask a doctor if symptoms worsen or do not improve after 5 days.
  • If pregnant or breastfeeding, consult a health professional before use.
Indications and Usage

Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*

Dosage and Administration

Directions:•Shake Well Before Use.• Adults (12 and Older) Spray 3-5 times onto the tongue three times daily. • Children (2-12) Spray 1-3 times onto the tongue three times daily. • Infants (0-2) Spray 1 time onto the tongue three times daily or as directed by your health care professional.

Description

Active Ingredients: Antigens 6X,12X,30X:  **Texas Grasses, **Texas Trees,**Texas Weeds, Echinacea 3X HPUS; Herbal  Drainage Remedies 3X:  Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum.

Section 50565-1

Keep Out of Reach of Children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6

Inactive Ingredients:USP Purified Water and Vegetable Glycerin.

Section 51945-4

*www.allergena.com/drugdisclaimer

**Standard antigen mix used in this product us cross-reactive with Zone 5 tree, weed and grass allergens. For a complete list of allergens visit www.allergena.com

Manufactured for Progena Professional Formulations

4820 Eubank Blvd. NE, ABQ, NM 87111, www.progena.com

Section 55105-1

Purpose:Relief from Sneezing, Runny Nose, Itchy Eyes and Sinus Congestion.*

Section 55106-9

Active Ingredients: Antigens 6X,12X,30X: **Texas Grasses, **Texas Trees,**Texas Weeds, Echinacea 3X HPUS; Herbal  Drainage Remedies 3X: Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum.

Section 60561-8

Other Information: Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.


Structured Label Content

Indications and Usage (34067-9)

Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*

Dosage and Administration (34068-7)

Directions:•Shake Well Before Use.• Adults (12 and Older) Spray 3-5 times onto the tongue three times daily. • Children (2-12) Spray 1-3 times onto the tongue three times daily. • Infants (0-2) Spray 1 time onto the tongue three times daily or as directed by your health care professional.

Warnings and Precautions (34071-1)

Warnings:

  • Use Only as directed.
  • Stop use and ask a doctor if symptoms worsen or do not improve after 5 days.
  • If pregnant or breastfeeding, consult a health professional before use.
Section 50565-1 (50565-1)

Keep Out of Reach of Children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients:USP Purified Water and Vegetable Glycerin.

Section 51945-4 (51945-4)

*www.allergena.com/drugdisclaimer

**Standard antigen mix used in this product us cross-reactive with Zone 5 tree, weed and grass allergens. For a complete list of allergens visit www.allergena.com

Manufactured for Progena Professional Formulations

4820 Eubank Blvd. NE, ABQ, NM 87111, www.progena.com

Section 55105-1 (55105-1)

Purpose:Relief from Sneezing, Runny Nose, Itchy Eyes and Sinus Congestion.*

Section 55106-9 (55106-9)

Active Ingredients: Antigens 6X,12X,30X: **Texas Grasses, **Texas Trees,**Texas Weeds, Echinacea 3X HPUS; Herbal  Drainage Remedies 3X: Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum.

Section 60561-8 (60561-8)

Other Information: Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.


Advanced Ingredient Data


Raw Label Data

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