Label: HAY FEVER- zerophyllum asphodeloides, alfalfa, avena sativa pollen, 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 pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4433-0, 55714-4433-1, 55714-4433-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 1, 2011
If you are a consumer or patient please visit this version.
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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 - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
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INGREDIENTS AND APPEARANCE
HAY FEVER
zerophyllum asphodeloides, alfalfa, avena sativa pollen, 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 pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4433 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xerophyllum Asphodeloides (UNII: 9I4XB1GP2B) (Xerophyllum Asphodeloides - UNII:9I4XB1GP2B) Xerophyllum Asphodeloides 30 [hp_X] in 1 g Alfalfa (UNII: DJO934BRBD) (Alfalfa - UNII:DJO934BRBD) Alfalfa 15 [hp_X] in 1 g Avena Sativa Pollen (UNII: A7IKY24TR7) (Avena Sativa Pollen - UNII:A7IKY24TR7) Avena Sativa Pollen 15 [hp_X] in 1 g Cynosurus Cristatus Pollen (UNII: SES68PF95U) (Cynosurus Cristatus Pollen - UNII:SES68PF95U) Cynosurus Cristatus Pollen 15 [hp_X] in 1 g Echinochloa Crus-galli Pollen (UNII: 6941ZR795V) (Echinochloa Crus-galli Pollen - UNII:6941ZR795V) Echinochloa Crus-galli Pollen 15 [hp_X] in 1 g Poa Pratensis Pollen (UNII: SCB8J7LS3T) (Poa Pratensis Pollen - UNII:SCB8J7LS3T) Poa Pratensis Pollen 15 [hp_X] in 1 g Anthoxanthum Odoratum Pollen (UNII: 2KIK19R45Y) (Anthoxanthum Odoratum Pollen - UNII:2KIK19R45Y) Anthoxanthum Odoratum Pollen 15 [hp_X] in 1 g Agrostis Gigantea Pollen (UNII: HU8V6E7HOA) (Agrostis Gigantea Pollen - UNII:HU8V6E7HOA) Agrostis Gigantea Pollen 15 [hp_X] in 1 g Bromus Secalinus Pollen (UNII: Q4T1SJ3046) (Bromus Secalinus Pollen - UNII:Q4T1SJ3046) Bromus Secalinus Pollen 15 [hp_X] in 1 g Alopecurus Pratensis Pollen (UNII: DG1ZL6W96V) (Alopecurus Pratensis Pollen - UNII:DG1ZL6W96V) Alopecurus Pratensis Pollen 15 [hp_X] in 1 g Phleum Pratense Pollen (UNII: 65M88RW2EG) (Phleum Pratense Pollen - UNII:65M88RW2EG) Phleum Pratense Pollen 15 [hp_X] in 1 g Festuca Pratensis Pollen (UNII: A0WFQ8P6N1) (Festuca Pratensis Pollen - UNII:A0WFQ8P6N1) Festuca Pratensis Pollen 15 [hp_X] in 1 g Holcus Lanatus Pollen (UNII: 70O1TP6H01) (Holcus Lanatus Pollen - UNII:70O1TP6H01) Holcus Lanatus Pollen 15 [hp_X] in 1 g Lolium Perenne Pollen (UNII: 4T81LB52R0) (Lolium Perenne Pollen - UNII:4T81LB52R0) Lolium Perenne Pollen 15 [hp_X] in 1 g Fagus Sylvatica Pollen (UNII: 63218N1ZBI) (Fagus Sylvatica Pollen - UNII:63218N1ZBI) Fagus Sylvatica Pollen 15 [hp_X] in 1 g Betula Pendula Pollen (UNII: ZL5TV40C5Y) (Betula Pendula Pollen - UNII:ZL5TV40C5Y) Betula Pendula Pollen 15 [hp_X] in 1 g Quercus Alba Pollen (UNII: Z4Y9ZSV4KK) (Quercus Alba Pollen - UNII:Z4Y9ZSV4KK) Quercus Alba Pollen 15 [hp_X] in 1 g Fraxinus Excelsior Pollen (UNII: 1824QUA0U3) (Fraxinus Excelsior Pollen - UNII:1824QUA0U3) Fraxinus Excelsior Pollen 15 [hp_X] in 1 g Corylus Americana Pollen (UNII: ZGS382Y3AV) (Corylus Americana Pollen - UNII:ZGS382Y3AV) Corylus Americana Pollen 15 [hp_X] in 1 g Populus Nigra Pollen (UNII: 0MGE63QPFJ) (Populus Nigra Pollen - UNII:0MGE63QPFJ) Populus Nigra Pollen 15 [hp_X] in 1 g Platanus Orientalis Pollen (UNII: Y1A4835L6K) (Platanus Orientalis Pollen - UNII:Y1A4835L6K) Platanus Orientalis Pollen 15 [hp_X] in 1 g Ulmus Glabra Pollen (UNII: T2K08L297Q) (Ulmus Glabra Pollen - UNII:T2K08L297Q) Ulmus Glabra Pollen 15 [hp_X] in 1 g Salix Alba Pollen (UNII: WQ580684IZ) (Salix Alba Pollen - UNII:WQ580684IZ) Salix Alba Pollen 15 [hp_X] in 1 g Narcissus Pseudonarcissus (UNII: Q2D0SKW2P4) (Narcissus Pseudonarcissus - UNII:Q2D0SKW2P4) Narcissus Pseudonarcissus 15 [hp_X] in 1 g Rosa Canina Flower (UNII: 81MCR2UQ6Q) (Rosa Canina Flower - UNII:81MCR2UQ6Q) Rosa Canina Flower 15 [hp_X] in 1 g Lilium Candidum Flower (UNII: COV655U2CJ) (Lilium Candidum Flower - UNII:COV655U2CJ) Lilium Candidum Flower 15 [hp_X] in 1 g Primula Vulgaris (UNII: KZ3PRK2V0J) (Primula Vulgaris - UNII:KZ3PRK2V0J) Primula Vulgaris 15 [hp_X] in 1 g Dianthus Caryophyllus Flower (UNII: B0D836E90S) (Dianthus Caryophyllus Flower - UNII:B0D836E90S) Dianthus Caryophyllus Flower 15 [hp_X] in 1 g Ulex Europaeus Flower (UNII: 398DBS1PXN) (Ulex Europaeus Flower - UNII:398DBS1PXN) Ulex Europaeus Flower 15 [hp_X] in 1 g Cytisus Scoparius Pollen (UNII: I0NS0040GH) (Cytisus Scoparius Pollen - UNII:I0NS0040GH) Cytisus Scoparius Pollen 15 [hp_X] in 1 g Calluna Vulgaris Pollen (UNII: 5Q1IE9V5YZ) (Calluna Vulgaris Pollen - UNII:5Q1IE9V5YZ) Calluna Vulgaris Pollen 15 [hp_X] in 1 g Crataegus Monogyna Pollen (UNII: X6049S3TX1) (Crataegus Monogyna Pollen - UNII:X6049S3TX1) Crataegus Monogyna Pollen 15 [hp_X] in 1 g Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 15 [hp_X] in 1 g Arundo Pliniana Root (UNII: ZXE7LB03WC) (Arundo Pliniana Root - UNII:ZXE7LB03WC) Arundo Pliniana Root 15 [hp_X] in 1 g Dysphania Ambrosioides (UNII: 4H5RSU087I) (Dysphania Ambrosioides - UNII:4H5RSU087I) Dysphania Ambrosioides 15 [hp_X] in 1 g Helianthemum Canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum Canadense 15 [hp_X] in 1 g Drosera Rotundifolia (UNII: QR44N9XPJQ) (Drosera Rotundifolia - UNII:QR44N9XPJQ) Drosera Rotundifolia 15 [hp_X] in 1 g Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top 15 [hp_X] in 1 g Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig 15 [hp_X] in 1 g Onosmodium Virginianum Whole (UNII: 604NK4250S) (Onosmodium Virginianum Whole - UNII:604NK4250S) Onosmodium Virginianum Whole 15 [hp_X] in 1 g Populus Tremuloides Leaf (UNII: 7IIH57D9E0) (Populus Tremuloides Leaf - UNII:7IIH57D9E0) Populus Tremuloides Leaf 15 [hp_X] in 1 g Populus Tremuloides Bark (UNII: 5543O0CEID) (Populus Tremuloides Bark - UNII:5543O0CEID) Populus Tremuloides Bark 15 [hp_X] in 1 g Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 15 [hp_X] in 1 g Sanguinaria Canadensis Root (UNII: N9288CD508) (Sanguinaria Canadensis Root - UNII:N9288CD508) Sanguinaria Canadensis Root 15 [hp_X] in 1 g Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium 15 [hp_X] in 1 g Elymus Repens Root (UNII: 3IXW0F6P8W) (Elymus Repens Root - UNII:3IXW0F6P8W) Elymus Repens Root 15 [hp_X] in 1 g Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens 15 [hp_X] in 1 g Wyethia Helenioides Root (UNII: J10PD1AQ0N) (Wyethia Helenioides Root - UNII:J10PD1AQ0N) Wyethia Helenioides Root 15 [hp_X] in 1 g Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion 15 [hp_X] in 1 g Ambrosia Artemisiifolia (UNII: 9W34L2CQ9A) (Ambrosia Artemisiifolia - UNII:9W34L2CQ9A) Ambrosia Artemisiifolia 15 [hp_X] in 1 g Ammonium Carbonate (UNII: NJ5VT0FKLJ) (Carbonate Ion - UNII:7UJQ5OPE7D) Carbonate Ion 15 [hp_X] in 1 g Aralia Racemosa Root (UNII: T90W4582DU) (Aralia Racemosa Root - UNII:T90W4582DU) Aralia Racemosa Root 15 [hp_X] in 1 g Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Cation (3+) 15 [hp_X] in 1 g Artemisia Vulgaris Root (UNII: 32MP823R8S) (Artemisia Vulgaris Root - UNII:32MP823R8S) Artemisia Vulgaris Root 15 [hp_X] in 1 g Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY) Bellis Perennis 15 [hp_X] in 1 g Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark 15 [hp_X] in 1 g Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 g Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 15 [hp_X] in 1 g Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top 15 [hp_X] in 1 g Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL) Euphrasia Stricta 15 [hp_X] in 1 g Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X] in 1 g Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide 15 [hp_X] in 1 g Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride 15 [hp_X] in 1 g Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 15 [hp_X] in 1 g Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Iodide Ion 15 [hp_X] in 1 g Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 15 [hp_X] in 1 g Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 g Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 15 [hp_X] in 1 g Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed 15 [hp_X] in 1 g Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top 15 [hp_X] in 1 g Trillium Erectum Root (UNII: AHW6F0T2X0) (Trillium Erectum Root - UNII:AHW6F0T2X0) Trillium Erectum Root 15 [hp_X] in 1 g Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG) Ustilago Maydis 15 [hp_X] in 1 g Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 3 [hp_X] in 1 g Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 g Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 3 [hp_X] in 1 g Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4433-1 28 g in 1 BOTTLE, GLASS 2 NDC:55714-4433-2 57 g in 1 BOTTLE, GLASS 3 NDC:55714-4433-0 7 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-4433)
