Allergies 1719p

Allergies 1719p
SPL v3
SPL
SPL Set ID 9d5dea47-5103-21a3-e053-2995a90aee78
Route
ORAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Protortonia Cacti (15 [hp_X]) Cynara Scolymus Leaf (16 [hp_X]) Onosmodium Virginianum (6 [hp_X]) Phytolacca Americana Root Yucca Filamentosa Saccharin Ginger Sodium Cation Populus Tremuloides Leaf Sanguinaria Canadensis Root Parthenium Hysterophorus Corn Silk Saccharomyces Cerevisiae Ulmus Rubra Bark Egg Shell, Cooked Schoenocaulon Officinale Seed Sambucus Nigra Flowering Top Lycopus Virginicus Anhydrous Lactose Black Mustard Seed Claviceps Purpurea Sclerotium Trillium Erectum Root Ascorbic Acid Aconitum Napellus Datura Stramonium Tobacco Leaf Allylthiourea Urtica Urens Elymus Repens Root Ustilago Maydis Wyethia Helenioides Root Xerophyllum Asphodeloides Apis Mellifera Taraxacum Officinale Aethusa Cynapium Amanita Muscaria Fruiting Body Aletris Farinosa Root Alfalfa Onion Garlic Ambrosia Artemisiifolia Arsenic Cation (3+) Artemisia Vulgaris Root Arundo Pliniana Root Avena Sativa Flowering Top Atropa Belladonna Bellis Perennis Lycoperdon Utriforme Fruiting Body Bromine Bryonia Alba Root Caffeine Oyster Shell Calcium Carbonate, Crude Calluna Vulgaris Flowering Top Capsicum Felis Catus Hair Matricaria Chamomilla Chelidonium Majus Dysphania Ambrosioides Cinnamon Helianthemum Canadense Canis Lupus Familiaris Hair Drosera Anglica Solanum Dulcamara Top Euphrasia Stricta Fagopyrum Esculentum Fagus Sylvatica Nut Alpine Strawberry Fraxinus Americana Bark Gelsemium Sempervirens Root Histamine House Dust Hyoscyamus Niger Abrus Precatorius Seed Juglans Regia Leaf Iodide Ion Cow Milk Rhododendron Tomentosum Leafy Twig Lilium Lancifolium Whole Flowering Toxicodendron Pubescens Leaf Lycopodium Clavatum Spore Echinacea, Unspecified Goldenseal Nitrate Ion Salix Nigra Bark Sulfur Populus Balsamifera Leaf Bud Quercus Robur Nut Mentha Piperita Nutmeg Solanum Lycopersicum Anacardium Occidentale Fruit Ptelea Trifoliata Bark Anemone Pulsatilla Rosa X Damascena Flowering Top Astacus Astacus Glycyrrhiza Glabra Juniperus Virginiana Twig Sucrose Solanum Nigrum Whole Solanum Tuberosum
Inactive Ingredients
Sucrose Caramel

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2019-01-01 Until 2024-05-20

Description

Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

Purpose

Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.


Medication Information

Purpose

Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

Description

Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

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 symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived (lactose-free) pellets.

Indications & Usage Section

Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

Dosage & Administration Section

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up take 6 pellets) as needed or directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Aconitum napellus 15x, Aethusa cynapium 15x, Agaricus muscarius 15x, Aletris farinosa 15x, Alfalfa 15x, Allium cepa 15x, Allium sativum 15x, Ambrosia artemisiaefolia 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Avena sativa 15x, Belladonna 15x, Bellis perrenis 15x, Bovista 15x, Bromium 15x, Bryonia 15x, Caffeinum 15x, Calcarea carbonica 15x, Calluna vulgaris, flos 15x, Capsicum annuum 15x, Cat hair 15x, Chamomilla 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cinnamomum 15x, Cistus canadensis 15x, Coccus cacti 15x, Cynara scolymus 15x, Dog hair 15x, Drosera 15x, Dulcamara 15x, Euphrasia officinalis 15x, Fagopyrum esculentum 15x, Fagus sylvatica 15x, Fragaria vesca 15x, Fraxinis americana 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, House dust 15x, Hyoscyamus niger 15x, Jequirity 15x, Juglans regia 15x, Kali iodatum 15x, Lac vaccinum 15x, Ledum palustre 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Lycopus virginicus 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Onosmodium virginianum 15x, Ova tosta 15x, Phytolacca decandra 15x, Populus candicans 15x, Populus tremuloides 15x, Ptelea trifoliata 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rhus toxicodendron 15x, Rosa damascena 15x, Sabadilla 15x, Saccharinum 15x, Saccharum lactis 15x, Salix nigra 15x, Sambucus nigra 15x, Sanguinaria canadensis 15x, Secale cornutum 15x, Stramonium 15x, Sulphur 15x, Tabacum 15x, Thiosinaminum 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Juniperus virginiana 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Parthenium 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x, Ulmus fulva 16x, Yucca filamentosa 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 symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived (lactose-free) pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up take 6 pellets) as needed or directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

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, Aethusa cynapium 15x, Agaricus muscarius 15x, Aletris farinosa 15x, Alfalfa 15x, Allium cepa 15x, Allium sativum 15x, Ambrosia artemisiaefolia 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Avena sativa 15x, Belladonna 15x, Bellis perrenis 15x, Bovista 15x, Bromium 15x, Bryonia 15x, Caffeinum 15x, Calcarea carbonica 15x, Calluna vulgaris, flos 15x, Capsicum annuum 15x, Cat hair 15x, Chamomilla 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cinnamomum 15x, Cistus canadensis 15x, Coccus cacti 15x, Cynara scolymus 15x, Dog hair 15x, Drosera 15x, Dulcamara 15x, Euphrasia officinalis 15x, Fagopyrum esculentum 15x, Fagus sylvatica 15x, Fragaria vesca 15x, Fraxinis americana 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, House dust 15x, Hyoscyamus niger 15x, Jequirity 15x, Juglans regia 15x, Kali iodatum 15x, Lac vaccinum 15x, Ledum palustre 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Lycopus virginicus 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Onosmodium virginianum 15x, Ova tosta 15x, Phytolacca decandra 15x, Populus candicans 15x, Populus tremuloides 15x, Ptelea trifoliata 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rhus toxicodendron 15x, Rosa damascena 15x, Sabadilla 15x, Saccharinum 15x, Saccharum lactis 15x, Salix nigra 15x, Sambucus nigra 15x, Sanguinaria canadensis 15x, Secale cornutum 15x, Stramonium 15x, Sulphur 15x, Tabacum 15x, Thiosinaminum 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Juniperus virginiana 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Parthenium 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x, Ulmus fulva 16x, Yucca filamentosa 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

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