FDA.reportPublic FDA data

Pollen-Weeds

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:56

Label at a glance#

ProductPollen-Weeds
Active ingredientCALLUNA VULGARIS FLOWERING TOP, ULMUS RUBRA BARK, FAGUS SYLVATICA NUT, FRAXINUS AMERICANA BARK, LILIUM LANCIFOLIUM WHOLE FLOWERING, BELLIS PERENNIS, ROSA DAMASCENA FLOWERING TOP, TRIFOLIUM PRATENSE FLOWER, SALIX NIGRA BARK, PARTHENIUM HYSTEROPHORUS, XEROPHYLLUM ASPHODELOIDES, EPINEPHRINE, ALFALFA, ALETRIS FARINOSA ROOT, ARTEMISIA VULGARIS ROOT, 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, USTILAGO MAYDIS, HISTAMINE DIHYDROCHLORIDE, JUNIPERUS VIRGINIANA TWIG, THYROID, UNSPECIFIED, 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, QUERCUS ROBUR NUT, GOLDENSEAL
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

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

Equal parts of Ginkgo biloba 11x, Hydrastis canadensis 11x, Taraxacum officinale 11x, Adrenalinum 20x, Aletris farinosa 20x, Alfalfa 20x, Allium cepa 20x, Antimonium tartaricum 20x, Arsenicum album 20x, Artemisia vulgaris 20x, Baptisia tinctoria 20x, Bellis perennis 20x, Berberis vulgaris 20x, Bryonia 20x, Calluna vulgaris, flos 20x, Chelidonium majus 20x, Chenopodium anthelminticum 20x, Dioscorea vilosa 20x, Euphrasia officinalis 20x, Fagus sylvatica 20x, Fraxinus americana 20x, Gelsemium sempervirens 20x, Histaminum hydrochloricum 20x, Kali bichromicum 20x, Kali iodatum 20x, Lachesis mutus 20x, Lilium tigrinum 20x, Lycopodium clavatum 20x, Lycopus virginicus 20x, Phytolacca decandra 20x, Populus candicans 20x, Populus tremuloides 20x, Ptelea trifoliata 20x, Pulsatilla 20x, Quercus glandium spiritus 20x, Rosa damascena 20x, Sabadilla 20x, Salix nigra 20x, Sambucus nigra 20x, Thyroidinum 20x, Trifolium pratense 20x, Trillium pendulum 20x, Triticum repens 20x, Urtica urens 20x, Ustilago maidis 20x, Wyethia helenoides 20x, Xerophyllum asphodeloides 20x, Juniperus virginiana 21x, Parthenium 21x, Ulmus fulva 21x, Yucca filamentosa 21x.

INACTIVE INGREDIENT SECTION

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

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 - 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
55714-4804-1Pollen-Weeds30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4804POLLEN-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,) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201208_99e92cc0-2c25-d814-e053-2a95a90aa258.zip

Products#

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

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-480455714-4804-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALLUNA VULGARIS FLOWERING TOPD9PC510CQVACTIB
ULMUS RUBRA BARK91QY4PXU8QACTIB
FAGUS SYLVATICA NUTI57ERU2601ACTIB
FRAXINUS AMERICANA BARK0B24UR1O1SACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
BELLIS PERENNIS2HU33I03UYACTIB
ROSA DAMASCENA FLOWERING TOP21W82Q764GACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
SALIX NIGRA BARKQU52J3A5B3ACTIB
PARTHENIUM HYSTEROPHORUS151F45R21PACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
XEROPHYLLUM ASPHODELOIDES9I4XB1GP2BACTIB
EPINEPHRINEYKH834O4BHACTIB
ALFALFADJO934BRBDACTIB
ALETRIS FARINOSA ROOTO021JGR97XACTIB
ARTEMISIA VULGARIS ROOT32MP823R8SACTIB
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
USTILAGO MAYDIS4K7Z7K7SWGACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
JUNIPERUS VIRGINIANA TWIG532BCG080LACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
ONION492225Q21HACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB

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.99e92cc0-2c25-d814-e053-2a95a90aa2582020-12-07WarningsExact identifier
ndc (package): 55714-4804-1
ndc (product): 55714-4804
ndc11 (package): 55714480401
spl id: b5e30eb6-f814-bb45-e053-2995a90a2c93
spl set id: 99e92cc0-2c25-d814-e053-2a95a90aa258

Reported adverse events (FAERS/openFDA)#

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