Allergies

Allergies
SPL v1
SPL
SPL Set ID f81da4af-0e85-ec3a-aa4f-12dd73dffe77
Route
ORAL
Published
Effective Date 2014-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cow Milk (60 [hp_X]) Skim Milk (30 [hp_X]) Cow Milk Fat (15 [hp_X]) Casein, Lactococcus Lactis Cultured, Aged (3 [hp_X]) Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, Aged Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, Aged Egg Felis Catus Skin Oryctolagus Cuniculus Skin Equus Caballus Skin Serinus Canaria Feather Gallus Gallus Feather Anas Platyrhynchos Feather Anser Anser Feather Melopsittacus Undulatus Feather Phasianus Colchicus Feather Meleagris Gallopavo Feather Felis Catus Hair Human Dander Canis Lupus Familiaris Hair Equus Caballus Hair Oryctolagus Cuniculus Hair Human Hair Human Skin Sheep Wool Bos Taurus Hair Capra Hircus Hair Cavia Porcellus Hair Mesocricetus Auratus Hair Fd&c Yellow No. 5 D&c Yellow No. 10 Food Yellow 3 Free Acid Carmoisine Amaranth Acid Ponceau 4r Tetraiodofluorescein Acid Red 1 Fd&c Blue No. 2 Sodium Acid Green 50 Benzoic Acid Potassium Propylparaben 2-phenylphenol Nitrite Ion Ascorbic Acid Tripolyphosphate Ion Aspartame Glutamic Acid Barley Corn Wheat Gluten Oat White Rice Rye Wheat Beef Pork Lamb Chicken Turkey Quahog, Unspecified Crab Leg, Unspecified Oyster, Unspecified Shrimp, Unspecified Scallop, Unspecified Xerophyllum Asphodeloides Aethusa Cynapium Alfalfa Aletris Farinosa Root 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 Aconitum Napellus Arundo Pliniana Root Helianthemum Canadense Drosera Rotundifolia Solanum Dulcamara Top Ledum Palustre Twig Onosmodium Virginianum Whole Pulsatilla Vulgaris Sanguinaria Canadensis Root Datura Stramonium Atropa Belladonna Capsicum Hyoscyamus Niger Solanum Nigrum Whole Tobacco Leaf Amanita Muscaria Fruiting Body Onion Garlic Anacardium Occidentale Fruit Lycoperdon Utriforme Fruiting Body Caffeine Cinnamon Cynara Scolymus Leaf Alpine Strawberry Abrus Precatorius Seed Glycyrrhiza Glabra Mentha Piperita Nutmeg Anhydrous Lactose Black Mustard Seed Allylthiourea Ustilago Maydis Ginger Aspergillus Niger Var. Niger Cladosporium Herbarum Brazil Nut Hazelnut, Unspecified Peanut English Walnut Trout, Unspecified Cod, Unspecified Haddock Tuna, Unspecified Salmon, Unspecified Herring, Unspecified Avena Sativa Pollen Cynosurus Cristatus Pollen Echinochloa Crus-galli Pollen Poa Pratensis Pollen Anthoxanthum Odoratum Pollen Agrostis Gigantea Pollen Bromus Secalinus 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 Dianthus Caryophyllus Flower Ulex Europaeus Flower Cytisus Scoparius Pollen Calluna Vulgaris Pollen Crataegus Monogyna Pollen House Dust Ambrosia Artemisiifolia Arsenic Cation (3+) Bromine Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude Matricaria Recutita Chelidonium Majus Euphrasia Stricta Gelsemium Sempervirens Root Histamine Juniperus Virginiana Twig Iodide Ion Solanum Lycopersicum Lycopodium Clavatum Spore Chloride Ion Toxicodendron Pubescens Leaf Schoenocaulon Officinale Seed Saccharin Solanum Tuberosum Sulfur Saccharomyces Cerevisiae Apis Mellifera Echinacea, Unspecified Goldenseal Taraxacum Officinale Alopecurus Pratensis Pollen Primula Vulgaris
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Allergies  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

Allergies  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

Warning:  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

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

Questions?  1.800.448.7256 

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, beet-derived sucrose pellets. 

Indications & Usage Section

Allergies  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, give 6 pellets) as needed or as 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

Allersodes 60x, Xerophyllum asphodeloides 30x, Aethusa cynapium 15x, Alfalfa 15x, Allersodes 15x, Ambrosia artemisiaefolia 15x, Arsenicum alb. 15x, Bromium 15x, Bryonia 15x, Calc. Carb. 15x, Chamomilla 15x, Chelidonium majus 15x, Euphrasia 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Juniperus virginiana 15x, Kali iod. 15x, Lycopersicum esculentum 15x, Lycopodium 15x, Nat. mur. 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sabadilla 15x, Saccharinum 15x, Sac lac. 15x, Solanum tuberosum 15x, Sulphur 15x, Torula cerevisiae 15x, Apis mel. 3x, Echinacea 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)

Warning:  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)

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 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, beet-derived sucrose pellets. 

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Allergies  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, give 6 pellets) as needed or as 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)

Allersodes 60x, Xerophyllum asphodeloides 30x, Aethusa cynapium 15x, Alfalfa 15x, Allersodes 15x, Ambrosia artemisiaefolia 15x, Arsenicum alb. 15x, Bromium 15x, Bryonia 15x, Calc. Carb. 15x, Chamomilla 15x, Chelidonium majus 15x, Euphrasia 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Juniperus virginiana 15x, Kali iod. 15x, Lycopersicum esculentum 15x, Lycopodium 15x, Nat. mur. 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sabadilla 15x, Saccharinum 15x, Sac lac. 15x, Solanum tuberosum 15x, Sulphur 15x, Torula cerevisiae 15x, Apis mel. 3x, Echinacea 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

All Sections (JSON)