FDA.reportPublic FDA data

Hay Fever

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:47

Label at a glance#

ProductHay Fever
Active ingredientXEROPHYLLUM ASPHODELOIDES, SALIX NIGRA BARK, LILIUM LANCIFOLIUM WHOLE FLOWERING, ULMUS RUBRA BARK, FAGUS SYLVATICA NUT, ALFALFA, FRAXINUS AMERICANA BARK, QUERCUS ROBUR NUT, BERBERIS VULGARIS ROOT BARK, ACONITUM NAPELLUS, ARUNDO PLINIANA ROOT, DYSPHANIA AMBROSIOIDES, HELIANTHEMUM CANADENSE, DROSERA ANGLICA, SOLANUM DULCAMARA TOP, RHODODENDRON TOMENTOSUM LEAFY TWIG, ONOSMODIUM VIRGINIANUM, POPULUS BALSAMIFERA LEAF BUD, POPULUS TREMULOIDES LEAF, ANEMONE PULSATILLA, SANGUINARIA CANADENSIS ROOT, DATURA STRAMONIUM, ELYMUS REPENS ROOT, URTICA URENS, WYETHIA HELENIOIDES ROOT, ONION, AMBROSIA ARTEMISIIFOLIA, AMMONIUM CARBONATE, ARALIA RACEMOSA ROOT, ARSENIC TRIOXIDE, ARTEMISIA VULGARIS ROOT, BELLIS PERENNIS, BRYONIA ALBA ROOT, CHELIDONIUM MAJUS, CALCIUM SULFIDE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, HISTAMINE DIHYDROCHLORIDE, POTASSIUM DICHROMATE, POTASSIUM IODIDE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, SCHOENOCAULON OFFICINALE SEED, SOLIDAGO VIRGAUREA FLOWERING TOP, TRILLIUM ERECTUM ROOT, GOLDENSEAL, USTILAGO MAYDIS, APIS MELLIFERA, ECHINACEA, UNSPECIFIED, TARAXACUM OFFICINALE, PARTHENIUM HYSTEROPHORUS, ROSA X DAMASCENA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms of late Summer and Fall 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

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Aconitum napellus 15x, Alfalfa 15x, Allium cepa 15x, Ambrosia artemisiaefolia 15x, Ammonium carbonicum 15x, Aralia racemosa 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Bellis perennis 15x, Berberis vulgaris 15x, Bryonia 15x, Calluna vulgaris, flos 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cistus canadensis 15x, Drosera 15x, Dulcamara 15x, Eupatorium perfoliatum 15x, Euphrasia officinalis 15x, Fagus sylvatica 15x, Fraxinus americana 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Kali bichromicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Ledum palustre 15x, Lillium tigrinum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Onosmodium virginianum 15x, Populus candicans 15x, Populus tremuloides 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rosa damascena 15x, Sabadilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Solidago virgaurea 15x, Stramonium 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Parthenium 16x, Ulmus fulva 16x.

OTC - PURPOSE SECTION

Formulated for associated symptoms of late Summer and Fall 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 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 not 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
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4834-1Hay Fever30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4834HAY FEVER (APIS MEL., ECHINACEA, HYDRASTIS, TARAXACUM, ACONITUM NAP., ALFALFA, ALLIUM CEPA, AMBROSIA, AMMON. CARB., ARALIA RAC., ARSENICUM ALB., ARTEMISIA., ARUNDO, BELLIS, BERBER. VULG., BRYONIA, CALLUNA VULGARIS, FLOS., CHELIDONIUM MAJ., CHENOPODIUM ANTH.,CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERF., EUPHRASIA, FAGUS SYL., FRAX. AMER., GELSEMIUM, HEPAR SULPH. CALC., HISTAMINE HYDROCHLORICUM, KALI BIC., KALI IOD., LACHESIS, LEDUM, LILIUM, LYCOPODIUM, NAT. MUR) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 1 package rows20201204_99d67160-8096-48e2-e053-2a95a90a296d.zip

Products#

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

DailyMed product names page 1 of 2 · 64 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-483455714-4834-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 56 matching rows.

Name, UNII, Kind table
NameUNIIKind
XEROPHYLLUM ASPHODELOIDES9I4XB1GP2BACTIB
SALIX NIGRA BARKQU52J3A5B3ACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
ULMUS RUBRA BARK91QY4PXU8QACTIB
FAGUS SYLVATICA NUTI57ERU2601ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ALFALFADJO934BRBDACTIB
FRAXINUS AMERICANA BARK0B24UR1O1SACTIB
QUERCUS ROBUR NUTQ7MU1F4GLYACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARUNDO PLINIANA ROOTZXE7LB03WCACTIB
DYSPHANIA AMBROSIOIDES4H5RSU087IACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
DROSERA ANGLICAJ61BY05EGYACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
ONOSMODIUM VIRGINIANUM604NK4250SACTIB
POPULUS BALSAMIFERA LEAF BUD9CQ6C00G3CACTIB
POPULUS TREMULOIDES LEAF7IIH57D9E0ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
ELYMUS REPENS ROOT3IXW0F6P8WACTIB
URTICA URENSIHN2NQ5OF9ACTIB
WYETHIA HELENIOIDES ROOTJ10PD1AQ0NACTIB
ONION492225Q21HACTIB
AMBROSIA ARTEMISIIFOLIA9W34L2CQ9AACTIB
AMMONIUM CARBONATENJ5VT0FKLJACTIM
ARALIA RACEMOSA ROOTT90W4582DUACTIB
ARSENIC TRIOXIDES7V92P67HOACTIM
ARTEMISIA VULGARIS ROOT32MP823R8SACTIB
BELLIS PERENNIS2HU33I03UYACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB

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
b5943e3c-c4e6-1640-e053-2a95a90aa83699d67160-8096-48e2-e053-2a95a90a296d2020-12-03WarningsExact identifier
spl id: b5943e3c-c4e6-1640-e053-2a95a90aa836
spl set id: 99d67160-8096-48e2-e053-2a95a90a296d

Reported adverse events (FAERS/openFDA)#

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