INDICATIONS & USAGE SECTION

Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.

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 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Xerophyllum asphodeloides 30, Adrenalinum 15x, Alfalfa 15x, Allersodes 15x, Histaminum hydrochloricum 15x, Juniperus virg. 15x, Populus can. 15x, Thyroidinum 15x, Trifolium prat. 15x, Ustilago maidis 15x, Allium cepa 10x, Antimon. tart. 10x, Arsenicum alb. 10x, Baptisia 10x, Berber. vulg. 10x, Bryonia 10x, Chelidonium majus 10x, Euphrasia 10x, Gelsemium 10x, Kali bic. 10x, Kali iod. 10x, Lachesis 10x, Lycopodium 10x, Pulsatilla 10x, Sabadilla 10x, Dioscorea 3x, Ginkgo 3x, Hydrastis 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms of Spring and early Summer pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warnings: Keep out of reach of children. Do no 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.

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.

PACKAGE LABEL

POLLEN WEEDS
xerophyllum asphodeloides, adrenalinum, alfalfa, aletris farinosa, artemisia vulgaris, bellis perennis, dysphania ambrosioides, lycopus virginicus, phytolacca american root, populus tremuloides, ptelea trifoliata, sambusus nigra, trillium erectum root, elymus repens root, urtica urens, wyethia helenioides, yucca filamentosa, avena sativa pollen, cynosurus cristatus pollen. echinochloa crus-galli pollen, poa pratensis pollen, anthoxanthum odoratum pollen, agrostis gigantea pollen, bromus secalinus pollen pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2309
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Xerophyllum Asphodeloides (UNII: 9I4XB1GP2B) (Xerophyllum Asphodeloides - UNII:9I4XB1GP2B)	Xerophyllum Asphodeloides	30 [hp_X] in 1 g
Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)	Epinephrine	15 [hp_X] in 1 g
Alfalfa (UNII: DJO934BRBD) (Alfalfa - UNII:DJO934BRBD)	Alfalfa	15 [hp_X] in 1 g
Aletris Farinosa Root (UNII: O021JGR97X) (Aletris Farinosa Root - UNII:O021JGR97X)	Aletris Farinosa Root	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
Dysphania Ambrosioides (UNII: 4H5RSU087I) (Dysphania Ambrosioides - UNII:4H5RSU087I)	Dysphania Ambrosioides	15 [hp_X] in 1 g
Lycopus Virginicus (UNII: TWH5125Q6F) (Lycopus Virginicus - UNII:TWH5125Q6F)	Lycopus Virginicus	15 [hp_X] in 1 g
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG)	Phytolacca Americana Root	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
Ptelea Trifoliata Bark (UNII: 5KQR6FTT0D) (Ptelea Trifoliata Bark - UNII:5KQR6FTT0D)	Ptelea Trifoliata Bark	15 [hp_X] in 1 g
Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U)	Sambucus Nigra 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
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
Yucca Filamentosa (UNII: T6VR38UJ9I) (Yucca Filamentosa - UNII:T6VR38UJ9I)	Yucca Filamentosa	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
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
Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3)	Histamine Dihydrochloride	15 [hp_X] in 1 g
Juniperus Virginiana Twig (UNII: 532BCG080L) (Juniperus Virginiana Twig - UNII:532BCG080L)	Juniperus Virginiana Twig	15 [hp_X] in 1 g
Populus Balsamifera Leaf Bud (UNII: 9CQ6C00G3C) (Populus Balsamifera Leaf Bud - UNII:9CQ6C00G3C)	Populus Balsamifera Leaf Bud	15 [hp_X] in 1 g
Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P)	Thyroid, Unspecified	15 [hp_X] in 1 g
Trifolium Pratense Flower (UNII: 4JS0838828) (Trifolium Pratense Flower - UNII:4JS0838828)	Trifolium Pratense Flower	15 [hp_X] in 1 g
Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG)	Ustilago Maydis	15 [hp_X] in 1 g
Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H)	Onion	10 [hp_X] in 1 g
Antimony Potassium Tartrate (UNII: DL6OZ476V3) (Antimony Cation (3+) - UNII:069647RPT5)	Antimony Potassium Tartrate	10 [hp_X] in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	10 [hp_X] in 1 g
Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU)	Baptisia Tinctoria Root	10 [hp_X] in 1 g
Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U)	Berberis Vulgaris Root Bark	10 [hp_X] in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	10 [hp_X] in 1 g
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN)	Chelidonium Majus	10 [hp_X] in 1 g
Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL)	Euphrasia Stricta	10 [hp_X] in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	10 [hp_X] in 1 g
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V)	Potassium Dichromate	10 [hp_X] in 1 g
Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q)	Potassium Iodide	10 [hp_X] in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I)	Lachesis Muta Venom	10 [hp_X] in 1 g
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	10 [hp_X] in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	10 [hp_X] in 1 g
Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO)	Schoenocaulon Officinale Seed	10 [hp_X] in 1 g
Dioscorea Villosa Tuber (UNII: IWY3IWX2G8) (Dioscorea Villosa Tuber - UNII:IWY3IWX2G8)	Dioscorea Villosa Tuber	3 [hp_X] in 1 g
Ginkgo (UNII: 19FUJ2C58T) (Ginkgo - UNII:19FUJ2C58T)	Ginkgo	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
Anthoxanthum Odoratum Pollen (UNII: 2KIK19R45Y) (Anthoxanthum Odoratum Pollen - UNII:2KIK19R45Y)	Anthoxanthum Odoratum Pollen	15 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description
Packaging
1	NDC:55714-2309-1	28 g in 1 BOTTLE, GLASS
2	NDC:55714-2309-2	57 g in 1 BOTTLE, GLASS
3	NDC:55714-2309-0	7 g in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2309)

Pollen - Weeds