Pollen - weeds

Pollen - weeds
SPL v1
SPL
SPL Set ID bf23808e-e14c-b813-6a49-ee7ec367811b
Route
ORAL
Published
Effective Date 2014-11-19
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Xerophyllum Asphodeloides (35 [hp_X]) Epinephrine (20 [hp_X]) Alfalfa (15 [hp_X]) Aletris Farinosa Root (8 [hp_X]) Artemisia Vulgaris Root Bellis Perennis Dysphania Ambrosioides Lycopus Virginicus Phytolacca Americana Root Populus Tremuloides Leaf Populus Tremuloides Bark Ptelea Trifoliata Bark Sambucus Nigra Flowering Top Trillium Erectum Root Elymus Repens Root Urtica Urens Wyethia Helenioides Root Yucca Filamentosa Avena Sativa Pollen Cynosurus Cristatus Pollen Echinochloa Crus-galli Pollen Poa Pratensis Pollen Agrostis Gigantea Pollen Bromus Secalinus Pollen Alopecurus Pratensis Pollen Phleum Pratense Pollen Festuca Pratensis Pollen Holcus Lanatus Pollen Lolium Perenne Pollen Fagus Sylvatica Pollen Betula Pendula Pollen Quercus Alba Pollen Fraxinus Excelsior Pollen Corylus Americana Pollen Populus Nigra Pollen Platanus Orientalis Pollen Ulmus Glabra Pollen Salix Alba Pollen Narcissus Pseudonarcissus Rosa Canina Flower Lilium Candidum Flower Primula Vulgaris Dianthus Caryophyllus Flower Ulex Europaeus Flower Cytisus Scoparius Pollen Calluna Vulgaris Pollen Crataegus Monogyna Pollen Histamine Juniperus Virginiana Twig Populus Balsamifera Leaf Bud Thyroid, Unspecified Trifolium Pratense Flower Ustilago Maydis Onion Antimony Cation (3+) Arsenic Cation (3+) Baptisia Tinctoria Root Berberis Vulgaris Root Bark Bryonia Alba Root Chelidonium Majus Euphrasia Stricta Gelsemium Sempervirens Root Dichromate Ion Iodide Ion Lachesis Muta Venom Lycopodium Clavatum Spore Pulsatilla Vulgaris Schoenocaulon Officinale Seed Dioscorea Villosa Tuber Ginkgo Goldenseal Taraxacum Officinale Anthoxanthum Odoratum Pollen
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-06-01

Description

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

Purpose

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.


Medication Information

Purpose

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

Description

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

Package Label

Warnings Section

Warnings:  Keep out of reach of children.  Do no use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

Questions Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

Otc Purpose Section

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

Indications & Usage Section

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Otc Active Ingredient Section

Xerophyllum asphodeloides 35, Adrenalinum 20x, Alfalfa 20x, Allersodes 20x, Histaminum hydrochloricum 20x, Juniperus virg. 20x, Populus can. 20x, Thyroidinum 20x, Trifolium prat. 20x, Ustilago maidis 20x, Allium cepa 15x, Antimon. tart. 15x, Arsenicum alb. 15x, Baptisia 15x, Berber. vulg. 15x, Bryonia 15x, Chelidonium majus 15x, Euphrasia 15x, Gelsemium 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Pulsatilla 15x, Sabadilla 15x, Dioscorea 8x, Ginkgo 8x, Hydrastis 8x, Taraxacum 8x, Dioscorea 3x, Ginkgo 3x, Hydrastis 3x, Taraxacum 3x.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

Otc Keep Out of Reach of Children Section

Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

Warnings:  Keep out of reach of children.  Do no use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions:  Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Xerophyllum asphodeloides 35, Adrenalinum 20x, Alfalfa 20x, Allersodes 20x, Histaminum hydrochloricum 20x, Juniperus virg. 20x, Populus can. 20x, Thyroidinum 20x, Trifolium prat. 20x, Ustilago maidis 20x, Allium cepa 15x, Antimon. tart. 15x, Arsenicum alb. 15x, Baptisia 15x, Berber. vulg. 15x, Bryonia 15x, Chelidonium majus 15x, Euphrasia 15x, Gelsemium 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Pulsatilla 15x, Sabadilla 15x, Dioscorea 8x, Ginkgo 8x, Hydrastis 8x, Taraxacum 8x, Dioscorea 3x, Ginkgo 3x, Hydrastis 3x, Taraxacum 3x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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