Hay 4834l

Hay 4834l
SPL v2
SPL
SPL Set ID 99d67160-8096-48e2-e053-2a95a90a296d
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Xerophyllum Asphodeloides (15 [hp_X]) Salix Nigra Bark (16 [hp_X]) Lilium Lancifolium Whole Flowering (6 [hp_X]) Ulmus Rubra Bark Fagus Sylvatica Nut Alfalfa Fraxinus Americana Bark Quercus Robur Nut Berberis Vulgaris Root Bark Aconitum Napellus Arundo Pliniana Root Dysphania Ambrosioides Helianthemum Canadense Drosera Anglica Solanum Dulcamara Top Rhododendron Tomentosum Leafy Twig Onosmodium Virginianum Populus Balsamifera Leaf Bud Populus Tremuloides Leaf Anemone Pulsatilla Sanguinaria Canadensis Root Datura Stramonium Elymus Repens Root Urtica Urens Wyethia Helenioides Root Onion Ambrosia Artemisiifolia Carbonate Ion Aralia Racemosa Root Arsenic Cation (3+) Artemisia Vulgaris Root Bellis Perennis Bryonia Alba Root Chelidonium Majus Calcium Sulfide Eupatorium Perfoliatum Flowering Top Euphrasia Stricta Gelsemium Sempervirens Root Histamine Dichromate Ion Iodide Ion Lachesis Muta Venom Lycopodium Clavatum Spore Chloride Ion Schoenocaulon Officinale Seed Solidago Virgaurea Flowering Top Trillium Erectum Root Goldenseal Ustilago Maydis Apis Mellifera Echinacea, Unspecified Taraxacum Officinale Parthenium Hysterophorus Rosa X Damascena Flowering Top
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02
Description

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

Purpose

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

Medication Information

Purpose

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

Description

Formulated for associated symptoms of late Summer and Fall 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 not 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

Otc Purpose Section

Formulated for associated symptoms of late Summer and Fall 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 alcohol 20%.

Indications & Usage Section

Formulated for associated symptoms of late Summer and Fall 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

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Aconitum napellus 15x, Alfalfa 15x, Allium cepa 15x, Ambrosia artemisiaefolia 15x, Ammonium carbonicum 15x, Aralia racemosa 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Bellis perennis 15x, Berberis vulgaris 15x, Bryonia 15x, Calluna vulgaris, flos 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cistus canadensis 15x, Drosera 15x, Dulcamara 15x, Eupatorium perfoliatum 15x, Euphrasia officinalis 15x, Fagus sylvatica 15x, Fraxinus americana 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Kali bichromicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Ledum palustre 15x, Lillium tigrinum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Onosmodium virginianum 15x, Populus candicans 15x, Populus tremuloides 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rosa damascena 15x, Sabadilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Solidago virgaurea 15x, Stramonium 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Parthenium 16x, Ulmus fulva 16x.

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 not 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

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms of late Summer and Fall 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 alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms of late Summer and Fall 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)

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Aconitum napellus 15x, Alfalfa 15x, Allium cepa 15x, Ambrosia artemisiaefolia 15x, Ammonium carbonicum 15x, Aralia racemosa 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Bellis perennis 15x, Berberis vulgaris 15x, Bryonia 15x, Calluna vulgaris, flos 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cistus canadensis 15x, Drosera 15x, Dulcamara 15x, Eupatorium perfoliatum 15x, Euphrasia officinalis 15x, Fagus sylvatica 15x, Fraxinus americana 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Kali bichromicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Ledum palustre 15x, Lillium tigrinum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Onosmodium virginianum 15x, Populus candicans 15x, Populus tremuloides 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rosa damascena 15x, Sabadilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Solidago virgaurea 15x, Stramonium 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Parthenium 16x, Ulmus fulva 16x.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:56.608938 · Updated: 2026-03-14T23:15:01.065113