Pollen 4804l

Pollen 4804l
SPL v2
SPL
SPL Set ID 99e92cc0-2c25-d814-e053-2a95a90aa258
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calluna Vulgaris Flowering Top (20 [hp_X]) Ulmus Rubra Bark (21 [hp_X]) Fagus Sylvatica Nut (11 [hp_X]) Fraxinus Americana Bark Lilium Lancifolium Whole Flowering Bellis Perennis Rosa Damascena Flowering Top Trifolium Pratense Flower Salix Nigra Bark Parthenium Hysterophorus Xerophyllum Asphodeloides Epinephrine Alfalfa Aletris Farinosa Root Artemisia Vulgaris Root Dysphania Ambrosioides Lycopus Virginicus Phytolacca Americana Root Populus Balsamifera Leaf Bud Populus Tremuloides Leaf Ptelea Trifoliata Bark Sambucus Nigra Flowering Top Trillium Erectum Root Elymus Repens Root Urtica Urens Wyethia Helenioides Root Yucca Filamentosa Ustilago Maydis Histamine Juniperus Virginiana Twig Thyroid, Unspecified 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 Anemone Pulsatilla Schoenocaulon Officinale Seed Dioscorea Villosa Tuber Ginkgo Taraxacum Officinale Quercus Robur Nut Goldenseal
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

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


Medication Information

Description

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

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

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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 sore throat,

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

Equal parts of Ginkgo biloba 11x, Hydrastis canadensis 11x, Taraxacum officinale 11x, Adrenalinum 20x, Aletris farinosa 20x, Alfalfa 20x, Allium cepa 20x, Antimonium tartaricum 20x, Arsenicum album 20x, Artemisia vulgaris 20x, Baptisia tinctoria 20x, Bellis perennis 20x, Berberis vulgaris 20x, Bryonia 20x, Calluna vulgaris, flos 20x, Chelidonium majus 20x, Chenopodium anthelminticum 20x, Dioscorea vilosa 20x, Euphrasia officinalis 20x, Fagus sylvatica 20x, Fraxinus americana 20x, Gelsemium sempervirens 20x, Histaminum hydrochloricum 20x, Kali bichromicum 20x, Kali iodatum 20x, Lachesis mutus 20x, Lilium tigrinum 20x, Lycopodium clavatum 20x, Lycopus virginicus 20x, Phytolacca decandra 20x, Populus candicans 20x, Populus tremuloides 20x, Ptelea trifoliata 20x, Pulsatilla 20x, Quercus glandium spiritus 20x, Rosa damascena 20x, Sabadilla 20x, Salix nigra 20x, Sambucus nigra 20x, Thyroidinum 20x, Trifolium pratense 20x, Trillium pendulum 20x, Triticum repens 20x, Urtica urens 20x, Ustilago maidis 20x, Wyethia helenoides 20x, Xerophyllum asphodeloides 20x, Juniperus virginiana 21x, Parthenium 21x, Ulmus fulva 21x, Yucca filamentosa 21x.

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)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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 sore throat,

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)

Equal parts of Ginkgo biloba 11x, Hydrastis canadensis 11x, Taraxacum officinale 11x, Adrenalinum 20x, Aletris farinosa 20x, Alfalfa 20x, Allium cepa 20x, Antimonium tartaricum 20x, Arsenicum album 20x, Artemisia vulgaris 20x, Baptisia tinctoria 20x, Bellis perennis 20x, Berberis vulgaris 20x, Bryonia 20x, Calluna vulgaris, flos 20x, Chelidonium majus 20x, Chenopodium anthelminticum 20x, Dioscorea vilosa 20x, Euphrasia officinalis 20x, Fagus sylvatica 20x, Fraxinus americana 20x, Gelsemium sempervirens 20x, Histaminum hydrochloricum 20x, Kali bichromicum 20x, Kali iodatum 20x, Lachesis mutus 20x, Lilium tigrinum 20x, Lycopodium clavatum 20x, Lycopus virginicus 20x, Phytolacca decandra 20x, Populus candicans 20x, Populus tremuloides 20x, Ptelea trifoliata 20x, Pulsatilla 20x, Quercus glandium spiritus 20x, Rosa damascena 20x, Sabadilla 20x, Salix nigra 20x, Sambucus nigra 20x, Thyroidinum 20x, Trifolium pratense 20x, Trillium pendulum 20x, Triticum repens 20x, Urtica urens 20x, Ustilago maidis 20x, Wyethia helenoides 20x, Xerophyllum asphodeloides 20x, Juniperus virginiana 21x, Parthenium 21x, Ulmus fulva 21x, Yucca filamentosa 21x.

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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