FDA.reportPublic FDA data

Pollen-Weeds

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:53

Label at a glance#

ProductPollen-Weeds
Active ingredientPARTHENIUM HYSTEROPHORUS, XEROPHYLLUM ASPHODELOIDES, ARTEMISIA VULGARIS ROOT, EPINEPHRINE, ALFALFA, ALETRIS FARINOSA ROOT, BELLIS PERENNIS, DYSPHANIA AMBROSIOIDES, LYCOPUS VIRGINICUS, PHYTOLACCA AMERICANA ROOT, POPULUS BALSAMIFERA LEAF BUD, POPULUS TREMULOIDES LEAF, PTELEA TRIFOLIATA BARK, SAMBUCUS NIGRA FLOWERING TOP, TRILLIUM ERECTUM ROOT, ELYMUS REPENS ROOT, URTICA URENS, WYETHIA HELENIOIDES ROOT, YUCCA FILAMENTOSA, HISTAMINE DIHYDROCHLORIDE, JUNIPERUS VIRGINIANA TWIG, THYROID, UNSPECIFIED, USTILAGO MAYDIS, ONION, ANTIMONY POTASSIUM TARTRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, CHELIDONIUM MAJUS, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, POTASSIUM IODIDE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, SCHOENOCAULON OFFICINALE SEED, DIOSCOREA VILLOSA TUBER, GINKGO, TARAXACUM OFFICINALE, GOLDENSEAL, QUERCUS ROBUR NUT, CALLUNA VULGARIS FLOWERING TOP, ULMUS RUBRA BARK, FAGUS SYLVATICA NUT, TRIFOLIUM PRATENSE FLOWER, FRAXINUS AMERICANA BARK, LILIUM LANCIFOLIUM WHOLE FLOWERING, ROSA DAMASCENA FLOWERING TOP, SALIX NIGRA BARK
Label structure9 sections

Label contents#

Full prescribing information#

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.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Ginkgo biloba 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Adrenalinum 15x, Aletris farinosa 15x, Alfalfa 15x, Allium cepa 15x, Antimonium tartaricum 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Baptisia tinctoria 15x, Bellis perennis 15x, Berberis vulgaris 15x, Bryonia 15x, Calluna vulgaris, flos 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Dioscorea vilosa 15x, Euphrasia officinalis 15x, Fagus sylvatica 15x, Fraxinus americana 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Kali bichromicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Lilium tigrinum 15x, Lycopodium clavatum 15x, Lycopus virginicus 15x, Phytolacca decandra 15x, Populus candicans 15x, Populus tremuloides 15x, Ptelea trifoliata 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rosa damascena 15x, Sabadilla 15x, Salix nigra 15x, Sambucus nigra 15x, Thyroidinum 15x, Trifolium pratense 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Juniperus virginiana 16x, Parthenium 16x, Ulmus fulva 16x, Yucca filamentosa 16x.

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, organie beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2500-1Pollen-Weeds28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2500POLLEN-WEEDS (GINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250210_9caafbca-c8f7-d898-e053-2995a90a357a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 59 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-250055714-2500-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
PARTHENIUM HYSTEROPHORUS151F45R21PACTIB
XEROPHYLLUM ASPHODELOIDES9I4XB1GP2BACTIB
ARTEMISIA VULGARIS ROOT32MP823R8SACTIB
EPINEPHRINEYKH834O4BHACTIB
ALFALFADJO934BRBDACTIB
ALETRIS FARINOSA ROOTO021JGR97XACTIB
BELLIS PERENNIS2HU33I03UYACTIB
DYSPHANIA AMBROSIOIDES4H5RSU087IACTIB
LYCOPUS VIRGINICUSTWH5125Q6FACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
POPULUS BALSAMIFERA LEAF BUD9CQ6C00G3CACTIB
POPULUS TREMULOIDES LEAF7IIH57D9E0ACTIB
PTELEA TRIFOLIATA BARK5KQR6FTT0DACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
TRILLIUM ERECTUM ROOTAHW6F0T2X0ACTIB
ELYMUS REPENS ROOT3IXW0F6P8WACTIB
URTICA URENSIHN2NQ5OF9ACTIB
WYETHIA HELENIOIDES ROOTJ10PD1AQ0NACTIB
YUCCA FILAMENTOSAT6VR38UJ9IACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
JUNIPERUS VIRGINIANA TWIG532BCG080LACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
ONION492225Q21HACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
DIOSCOREA VILLOSA TUBERIWY3IWX2G8ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pollen-WeedsGINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,Newton Laboratories, Inc.9caafbca-c8f7-d898-e053-2995a90a357a2025-02-07WarningsExact identifier
ndc (package): 55714-2500-1
ndc (product): 55714-2500
ndc11 (package): 55714250001
spl id: 2d95425f-f2e8-8194-e063-6294a90aa39f
spl set id: 9caafbca-c8f7-d898-e053-2995a90a357a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.