Hay Fever

Hay Fever
SPL v1
SPL
SPL Set ID 4fe7cb30-fbad-7745-2205-2419ccfebd81
Route
ORAL
Published
Effective Date 2014-11-18
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Xerophyllum Asphodeloides (30 [hp_X]) Alfalfa (15 [hp_X]) Avena Sativa Pollen (3 [hp_X]) Cynosurus Cristatus Pollen Echinochloa Crus-galli Pollen Poa Pratensis Pollen Anthoxanthum Odoratum Pollen Agrostis Gigantea Pollen Bromus Secalinus Pollen Alopecurus Pratensis 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 Primula Vulgaris Dianthus Caryophyllus Flower Ulex Europaeus Flower Cytisus Scoparius Pollen Calluna Vulgaris Pollen Crataegus Monogyna Pollen Aconitum Napellus Arundo Pliniana Root Dysphania Ambrosioides Helianthemum Canadense Drosera Rotundifolia Solanum Dulcamara Top Ledum Palustre Twig Onosmodium Virginianum Whole Populus Tremuloides Leaf Populus Tremuloides Bark Pulsatilla Vulgaris 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 Berberis Vulgaris Root Bark Bryonia Alba Root Chelidonium Majus Eupatorium Perfoliatum Flowering Top Euphrasia Stricta Gelsemium Sempervirens Root Calcium Sulfide Histamine Dichromate Ion Iodide Ion Lachesis Muta Venom Lycopodium Clavatum Spore Chloride Ion Schoenocaulon Officinale Seed Solidago Virgaurea Flowering Top Trillium Erectum Root Ustilago Maydis Apis Mellifera Echinacea, Unspecified Goldenseal Taraxacum Officinale
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-06-01

Description

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

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 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:  Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section

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

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. 

Otc Active Ingredient Section

Xerophyllum 30x, Alfalfa 15x, Allersodes 15x, Allium cepa 15x, Ambrosia 15x, Ammon. carb. 15x, Aralia rac. 15x, Arsenicum alb. 15x, Artemisia 15x, Bellis 15x, Berber. vulg. 15x, Bryonia 15x , Chelidonium maj. 15x, Eupatorium perf. 15x, Euphrasia 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Nat.mur. 15x, Sabadilla 15x, Solidago 15x, Trillium 15x, Ustilago maidis 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 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:  Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. 

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Xerophyllum 30x, Alfalfa 15x, Allersodes 15x, Allium cepa 15x, Ambrosia 15x, Ammon. carb. 15x, Aralia rac. 15x, Arsenicum alb. 15x, Artemisia 15x, Bellis 15x, Berber. vulg. 15x, Bryonia 15x , Chelidonium maj. 15x, Eupatorium perf. 15x, Euphrasia 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Nat.mur. 15x, Sabadilla 15x, Solidago 15x, Trillium 15x, Ustilago maidis 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

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