INDICATIONS & USAGE SECTION

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Xerophyllum asphodeloides 35, Adrenalinum 20x, Alfalfa 20x, Allersodes 20x, Histaminum hydrochloricum 20x, Juniperus virg. 20x, Populus can. 20x, Thyroidinum 20x, Trifolium prat. 20x, Ustilago maidis 20x, Allium cepa 15x, Antimon. tart. 15x, Arsenicum alb. 15x, Baptisia 15x, Berber. vulg. 15x, Bryonia 15x, Chelidonium majus 15x, Euphrasia 15x, Gelsemium 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Pulsatilla 15x, Sabadilla 15x, Dioscorea 8x, Ginkgo 8x, Hydrastis 8x, Taraxacum 8x, Dioscorea 3x, Ginkgo 3x, Hydrastis 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms of Spring and early Summer pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swellings and pharyngitis.

INACTIVE INGREDIENT SECTION

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

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 liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:55714-4570
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Xerophyllum Asphodeloides (UNII: 9I4XB1GP2B) (Xerophyllum Asphodeloides - UNII:9I4XB1GP2B)	Xerophyllum Asphodeloides	35 [hp_X] in 1 mL
Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)	Epinephrine	20 [hp_X] in 1 mL
Alfalfa (UNII: DJO934BRBD) (Alfalfa - UNII:DJO934BRBD)	Alfalfa	20 [hp_X] in 1 mL
Aletris Farinosa Root (UNII: O021JGR97X) (Aletris Farinosa Root - UNII:O021JGR97X)	Aletris Farinosa Root	20 [hp_X] in 1 mL
Artemisia Vulgaris Root (UNII: 32MP823R8S) (Artemisia Vulgaris Root - UNII:32MP823R8S)	Artemisia Vulgaris Root	20 [hp_X] in 1 mL
Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY)	Bellis Perennis	20 [hp_X] in 1 mL
Dysphania Ambrosioides (UNII: 4H5RSU087I) (Dysphania Ambrosioides - UNII:4H5RSU087I)	Dysphania Ambrosioides	20 [hp_X] in 1 mL
Lycopus Virginicus (UNII: TWH5125Q6F) (Lycopus Virginicus - UNII:TWH5125Q6F)	Lycopus Virginicus	20 [hp_X] in 1 mL
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG)	Phytolacca Americana Root	20 [hp_X] in 1 mL
Populus Tremuloides Leaf (UNII: 7IIH57D9E0) (Populus Tremuloides Leaf - UNII:7IIH57D9E0)	Populus Tremuloides Leaf	20 [hp_X] in 1 mL
Populus Tremuloides Bark (UNII: 5543O0CEID) (Populus Tremuloides Bark - UNII:5543O0CEID)	Populus Tremuloides Bark	20 [hp_X] in 1 mL
Ptelea Trifoliata Bark (UNII: 5KQR6FTT0D) (Ptelea Trifoliata Bark - UNII:5KQR6FTT0D)	Ptelea Trifoliata Bark	20 [hp_X] in 1 mL
Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U)	Sambucus Nigra Flowering Top	20 [hp_X] in 1 mL
Trillium Erectum Root (UNII: AHW6F0T2X0) (Trillium Erectum Root - UNII:AHW6F0T2X0)	Trillium Erectum Root	20 [hp_X] in 1 mL
Elymus Repens Root (UNII: 3IXW0F6P8W) (Elymus Repens Root - UNII:3IXW0F6P8W)	Elymus Repens Root	20 [hp_X] in 1 mL
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9)	Urtica Urens	20 [hp_X] in 1 mL
Wyethia Helenioides Root (UNII: J10PD1AQ0N) (Wyethia Helenioides Root - UNII:J10PD1AQ0N)	Wyethia Helenioides Root	20 [hp_X] in 1 mL
Yucca Filamentosa (UNII: T6VR38UJ9I) (Yucca Filamentosa - UNII:T6VR38UJ9I)	Yucca Filamentosa	20 [hp_X] in 1 mL
Avena Sativa Pollen (UNII: A7IKY24TR7) (Avena Sativa Pollen - UNII:A7IKY24TR7)	Avena Sativa Pollen	20 [hp_X] in 1 mL
Cynosurus Cristatus Pollen (UNII: SES68PF95U) (Cynosurus Cristatus Pollen - UNII:SES68PF95U)	Cynosurus Cristatus Pollen	20 [hp_X] in 1 mL
Echinochloa Crus-galli Pollen (UNII: 6941ZR795V) (Echinochloa Crus-galli Pollen - UNII:6941ZR795V)	Echinochloa Crus-galli Pollen	20 [hp_X] in 1 mL
Poa Pratensis Pollen (UNII: SCB8J7LS3T) (Poa Pratensis Pollen - UNII:SCB8J7LS3T)	Poa Pratensis Pollen	20 [hp_X] in 1 mL
Agrostis Gigantea Pollen (UNII: HU8V6E7HOA) (Agrostis Gigantea Pollen - UNII:HU8V6E7HOA)	Agrostis Gigantea Pollen	20 [hp_X] in 1 mL
Bromus Secalinus Pollen (UNII: Q4T1SJ3046) (Bromus Secalinus Pollen - UNII:Q4T1SJ3046)	Bromus Secalinus Pollen	20 [hp_X] in 1 mL
Alopecurus Pratensis Pollen (UNII: DG1ZL6W96V) (Alopecurus Pratensis Pollen - UNII:DG1ZL6W96V)	Alopecurus Pratensis Pollen	20 [hp_X] in 1 mL
Phleum Pratense Pollen (UNII: 65M88RW2EG) (Phleum Pratense Pollen - UNII:65M88RW2EG)	Phleum Pratense Pollen	20 [hp_X] in 1 mL
Festuca Pratensis Pollen (UNII: A0WFQ8P6N1) (Festuca Pratensis Pollen - UNII:A0WFQ8P6N1)	Festuca Pratensis Pollen	20 [hp_X] in 1 mL
Holcus Lanatus Pollen (UNII: 70O1TP6H01) (Holcus Lanatus Pollen - UNII:70O1TP6H01)	Holcus Lanatus Pollen	20 [hp_X] in 1 mL
Lolium Perenne Pollen (UNII: 4T81LB52R0) (Lolium Perenne Pollen - UNII:4T81LB52R0)	Lolium Perenne Pollen	20 [hp_X] in 1 mL
Fagus Sylvatica Pollen (UNII: 63218N1ZBI) (Fagus Sylvatica Pollen - UNII:63218N1ZBI)	Fagus Sylvatica Pollen	20 [hp_X] in 1 mL
Betula Pendula Pollen (UNII: ZL5TV40C5Y) (Betula Pendula Pollen - UNII:ZL5TV40C5Y)	Betula Pendula Pollen	20 [hp_X] in 1 mL
Quercus Alba Pollen (UNII: Z4Y9ZSV4KK) (Quercus Alba Pollen - UNII:Z4Y9ZSV4KK)	Quercus Alba Pollen	20 [hp_X] in 1 mL
Fraxinus Excelsior Pollen (UNII: 1824QUA0U3) (Fraxinus Excelsior Pollen - UNII:1824QUA0U3)	Fraxinus Excelsior Pollen	20 [hp_X] in 1 mL
Corylus Americana Pollen (UNII: ZGS382Y3AV) (Corylus Americana Pollen - UNII:ZGS382Y3AV)	Corylus Americana Pollen	20 [hp_X] in 1 mL
Populus Nigra Pollen (UNII: 0MGE63QPFJ) (Populus Nigra Pollen - UNII:0MGE63QPFJ)	Populus Nigra Pollen	20 [hp_X] in 1 mL
Platanus Orientalis Pollen (UNII: Y1A4835L6K) (Platanus Orientalis Pollen - UNII:Y1A4835L6K)	Platanus Orientalis Pollen	20 [hp_X] in 1 mL
Ulmus Glabra Pollen (UNII: T2K08L297Q) (Ulmus Glabra Pollen - UNII:T2K08L297Q)	Ulmus Glabra Pollen	20 [hp_X] in 1 mL
Salix Alba Pollen (UNII: WQ580684IZ) (Salix Alba Pollen - UNII:WQ580684IZ)	Salix Alba Pollen	20 [hp_X] in 1 mL
Narcissus Pseudonarcissus (UNII: Q2D0SKW2P4) (Narcissus Pseudonarcissus - UNII:Q2D0SKW2P4)	Narcissus Pseudonarcissus	20 [hp_X] in 1 mL
Rosa Canina Flower (UNII: 81MCR2UQ6Q) (Rosa Canina Flower - UNII:81MCR2UQ6Q)	Rosa Canina Flower	20 [hp_X] in 1 mL
Lilium Candidum Flower (UNII: COV655U2CJ) (Lilium Candidum Flower - UNII:COV655U2CJ)	Lilium Candidum Flower	20 [hp_X] in 1 mL
Primula Vulgaris (UNII: KZ3PRK2V0J) (Primula Vulgaris - UNII:KZ3PRK2V0J)	Primula Vulgaris	20 [hp_X] in 1 mL
Dianthus Caryophyllus Flower (UNII: B0D836E90S) (Dianthus Caryophyllus Flower - UNII:B0D836E90S)	Dianthus Caryophyllus Flower	20 [hp_X] in 1 mL
Ulex Europaeus Flower (UNII: 398DBS1PXN) (Ulex Europaeus Flower - UNII:398DBS1PXN)	Ulex Europaeus Flower	20 [hp_X] in 1 mL
Cytisus Scoparius Pollen (UNII: I0NS0040GH) (Cytisus Scoparius Pollen - UNII:I0NS0040GH)	Cytisus Scoparius Pollen	20 [hp_X] in 1 mL
Calluna Vulgaris Pollen (UNII: 5Q1IE9V5YZ) (Calluna Vulgaris Pollen - UNII:5Q1IE9V5YZ)	Calluna Vulgaris Pollen	20 [hp_X] in 1 mL
Crataegus Monogyna Pollen (UNII: X6049S3TX1) (Crataegus Monogyna Pollen - UNII:X6049S3TX1)	Crataegus Monogyna Pollen	20 [hp_X] in 1 mL
Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3)	Histamine Dihydrochloride	20 [hp_X] in 1 mL
Juniperus Virginiana Twig (UNII: 532BCG080L) (Juniperus Virginiana Twig - UNII:532BCG080L)	Juniperus Virginiana Twig	20 [hp_X] in 1 mL
Populus Balsamifera Leaf Bud (UNII: 9CQ6C00G3C) (Populus Balsamifera Leaf Bud - UNII:9CQ6C00G3C)	Populus Balsamifera Leaf Bud	20 [hp_X] in 1 mL
Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P)	Thyroid, Unspecified	20 [hp_X] in 1 mL
Trifolium Pratense Flower (UNII: 4JS0838828) (Trifolium Pratense Flower - UNII:4JS0838828)	Trifolium Pratense Flower	20 [hp_X] in 1 mL
Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG)	Ustilago Maydis	20 [hp_X] in 1 mL
Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H)	Onion	15 [hp_X] in 1 mL
Antimony Potassium Tartrate (UNII: DL6OZ476V3) (Antimony Cation (3+) - UNII:069647RPT5)	Antimony Potassium Tartrate	15 [hp_X] in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	15 [hp_X] in 1 mL
Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU)	Baptisia Tinctoria Root	15 [hp_X] in 1 mL
Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U)	Berberis Vulgaris Root Bark	15 [hp_X] in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	15 [hp_X] in 1 mL
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN)	Chelidonium Majus	15 [hp_X] in 1 mL
Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL)	Euphrasia Stricta	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V)	Potassium Dichromate	15 [hp_X] in 1 mL
Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q)	Potassium Iodide	15 [hp_X] in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I)	Lachesis Muta Venom	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO)	Schoenocaulon Officinale Seed	15 [hp_X] in 1 mL
Dioscorea Villosa Tuber (UNII: IWY3IWX2G8) (Dioscorea Villosa Tuber - UNII:IWY3IWX2G8)	Dioscorea Villosa Tuber	8 [hp_X] in 1 mL
Ginkgo (UNII: 19FUJ2C58T) (Ginkgo - UNII:19FUJ2C58T)	Ginkgo	8 [hp_X] in 1 mL
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV)	Goldenseal	8 [hp_X] in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375)	Taraxacum Officinale	8 [hp_X] in 1 mL
Anthoxanthum Odoratum Pollen (UNII: 2KIK19R45Y) (Anthoxanthum Odoratum Pollen - UNII:2KIK19R45Y)	Anthoxanthum Odoratum Pollen	20 [hp_X] in 1 mL

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

#	Item Code	Package Description
Packaging
1	NDC:55714-4570-1	30 mL in 1 BOTTLE, GLASS
2	NDC:55714-4570-2	59 mL in 1 BOTTLE, GLASS
3	NDC:55714-4570-0	15 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4570)

Pollen - Weeds