Allergies 4855l

Allergies 4855l
SPL v1
SPL
SPL Set ID 0631d5e5-9da4-bcb7-e063-6394a90a62de
Route
ORAL
Published
Effective Date 2023-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ulmus Rubra Bark (21 [hp_X]) Egg Shell, Cooked (20 [hp_X]) Schoenocaulon Officinale Seed (11 [hp_X]) Sambucus Nigra Flowering Top Sanguinaria Canadensis Root Lycopus Virginicus Anhydrous Lactose Claviceps Purpurea Sclerotium Trillium Erectum Root Ascorbic Acid Black Mustard Seed Datura Stramonium Tobacco Leaf Allylthiourea Urtica Urens Elymus Repens Root Ustilago Maydis Wyethia Helenioides Root Xerophyllum Asphodeloides Apis Mellifera Taraxacum Officinale Aconitum Napellus 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 Protortonia Cacti Cynara Scolymus Leaf 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 Onosmodium Virginianum Phytolacca Americana Root Yucca Filamentosa Saccharin Echinacea, Unspecified Goldenseal Toxicodendron Pubescens Leaf Salix Nigra Bark Sulfur Populus Balsamifera Leaf Bud Quercus Robur Nut Mentha Piperita Nutmeg Solanum Lycopersicum Anacardium Occidentale Fruit Ptelea Trifoliata Bark Lycopodium Clavatum Spore Anemone Pulsatilla Rosa X Damascena Flowering Top Astacus Astacus Glycyrrhiza Glabra Juniperus Virginiana Twig Sucrose Nitrate Ion Solanum Nigrum Whole Solanum Tuberosum Parthenium Hysterophorus Ginger Sodium Cation Populus Tremuloides Leaf Corn Silk Saccharomyces Cerevisiae
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-09-25
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: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

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: Ages 12 and up take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Apis mel 11x, Echinacea 11x, Hydrastis 11x, Taraxacum 11x, Aconitum nap 20x, Aethusa cynapium 20x, Agaricus musc 20x, Aletris 20x, Alfalfa 20x, Allium cepa 20x, Allium sat 20x, Ambrosia 20x, Arsenicum alb 20x, Artemisia 20x, Arundo ma 20x, Avena 20x, Belladonna 20x, Bellis 20x, Bovista 20x, Bromium 20x, Bryonia 20x, Caffeinum 20x, Calc carb 20x, Calluna vulgaris, flos 20x, Capsicum 20x, Cat hair 20x, Chamomilla 20x, Chelidonium maj 20x, Chenopodium anth 20x, Cinnamomum 20x, Cistus canadensis 20x, Coccus 20x, Cynara 20x, Dog hair 20x, Drosera 20x, Dulcamara 20x, Euphrasia 20x, Fagopyrum 20x, Fagus syl 20x, Fragaria 20x, Frax amer 20x, Gelsemium 20x, Histaminum hydro 20x, House dust 20x, Hyoscyamus 20x, Jequirity 20x, Juglans reg 20x, Kali iod 20x, Lac vac 20x, Ledum 20x, Lilium 20x, Lycopodium 20x, Lycopus 20x, Mentha pip 20x, Nat mur 20x, Nux mosch 20x, Onosmodium virginianum 20x, Ova tosta 20x, Phytolacca 20x, Populus can 20x, Populus trem 20x, Ptelea 20x, Pulsatilla 20x, Quercus gland sp 20x, Rhus tox 20x, Rosa dam 20x, Sabadilla 20x, Saccharinum 20x, Sac lac 20x, Salix nig 20x, Sambucus nig 20x, Sanguinaria 20x, Secale 20x, Stramonium 20x, Sulphur 20x, Tabacum 20x, Thiosinaminum 20x, Trillium 20x, Triticum 20x, Urtica ur 20x, Ustilago maidis 20x, Wyethia 20x, Xerophyllum 20x, Zingiber 20x, Anacardium occ 21x, Ascorbic ac 21x, Astacus 21x, Glycyrrhiza 21x, Juniperus virg 21x, Lycopersicum 21x, Nat nitricum 21x, Parthenium 21x, Saccharum off 21x, Sinapis nig 21x, Solanum nig 21x, Solanum tub 21x, Stigmata 21x, Torula cerevisiae 21x, Ulmus fulv 21x, Yucca 21x.

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

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: Ages 12 and up take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Apis mel 11x, Echinacea 11x, Hydrastis 11x, Taraxacum 11x, Aconitum nap 20x, Aethusa cynapium 20x, Agaricus musc 20x, Aletris 20x, Alfalfa 20x, Allium cepa 20x, Allium sat 20x, Ambrosia 20x, Arsenicum alb 20x, Artemisia 20x, Arundo ma 20x, Avena 20x, Belladonna 20x, Bellis 20x, Bovista 20x, Bromium 20x, Bryonia 20x, Caffeinum 20x, Calc carb 20x, Calluna vulgaris, flos 20x, Capsicum 20x, Cat hair 20x, Chamomilla 20x, Chelidonium maj 20x, Chenopodium anth 20x, Cinnamomum 20x, Cistus canadensis 20x, Coccus 20x, Cynara 20x, Dog hair 20x, Drosera 20x, Dulcamara 20x, Euphrasia 20x, Fagopyrum 20x, Fagus syl 20x, Fragaria 20x, Frax amer 20x, Gelsemium 20x, Histaminum hydro 20x, House dust 20x, Hyoscyamus 20x, Jequirity 20x, Juglans reg 20x, Kali iod 20x, Lac vac 20x, Ledum 20x, Lilium 20x, Lycopodium 20x, Lycopus 20x, Mentha pip 20x, Nat mur 20x, Nux mosch 20x, Onosmodium virginianum 20x, Ova tosta 20x, Phytolacca 20x, Populus can 20x, Populus trem 20x, Ptelea 20x, Pulsatilla 20x, Quercus gland sp 20x, Rhus tox 20x, Rosa dam 20x, Sabadilla 20x, Saccharinum 20x, Sac lac 20x, Salix nig 20x, Sambucus nig 20x, Sanguinaria 20x, Secale 20x, Stramonium 20x, Sulphur 20x, Tabacum 20x, Thiosinaminum 20x, Trillium 20x, Triticum 20x, Urtica ur 20x, Ustilago maidis 20x, Wyethia 20x, Xerophyllum 20x, Zingiber 20x, Anacardium occ 21x, Ascorbic ac 21x, Astacus 21x, Glycyrrhiza 21x, Juniperus virg 21x, Lycopersicum 21x, Nat nitricum 21x, Parthenium 21x, Saccharum off 21x, Sinapis nig 21x, Solanum nig 21x, Solanum tub 21x, Stigmata 21x, Torula cerevisiae 21x, Ulmus fulv 21x, Yucca 21x.

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: 2026-02-15T12:11:15.991418 · Updated: 2026-03-14T23:16:26.346541