Label: HAY FEVER- apis mellifica, echinacea, hydrastis canadensis, taraxacum officinale, aconitum napellus, alfalfa, allium cepa, ambrosia artemisiaefolia, ammonium carbonicum, aralia racemosa, arsenicum album, artemisia vulgaris, arundo mauritanica, bellis perennis, berberis vulgaris, bryonia, calluna vulgaris, flos, chelidonium majus, chenopodium anthelminticum, cistus canadensis, drosera, dulcamara, eupatorium perfoliatum, euphrasia officinalis, fagus sylvatica, fraxinus americana, gelsemium sempervirens liquid

  • NDC Code(s): 55714-2562-1
  • Packager: Newton Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 18, 2020

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  • INDICATIONS & USAGE SECTION

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

  • 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • 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

  • INACTIVE INGREDIENT SECTION

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

  • 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

  • INGREDIENTS AND APPEARANCE
    HAY FEVER 
    apis mellifica, echinacea, hydrastis canadensis, taraxacum officinale, aconitum napellus, alfalfa, allium cepa, ambrosia artemisiaefolia, ammonium carbonicum, aralia racemosa, arsenicum album, artemisia vulgaris, arundo mauritanica, bellis perennis, berberis vulgaris, bryonia, calluna vulgaris, flos, chelidonium majus, chenopodium anthelminticum, cistus canadensis, drosera, dulcamara, eupatorium perfoliatum, euphrasia officinalis, fagus sylvatica, fraxinus americana, gelsemium sempervirens liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2562
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING15 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE15 [hp_X]  in 1 mL
    POPULUS BALSAMIFERA LEAF BUD (UNII: 9CQ6C00G3C) (POPULUS BALSAMIFERA LEAF BUD - UNII:9CQ6C00G3C) POPULUS BALSAMIFERA LEAF BUD15 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP15 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA15 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
    ONOSMODIUM VIRGINIANUM (UNII: 604NK4250S) (ONOSMODIUM VIRGINIANUM - UNII:604NK4250S) ONOSMODIUM VIRGINIANUM15 [hp_X]  in 1 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED15 [hp_X]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT15 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP15 [hp_X]  in 1 mL
    TRILLIUM ERECTUM ROOT (UNII: AHW6F0T2X0) (TRILLIUM ERECTUM ROOT - UNII:AHW6F0T2X0) TRILLIUM ERECTUM ROOT15 [hp_X]  in 1 mL
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q) ULMUS RUBRA BARK16 [hp_X]  in 1 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE15 [hp_X]  in 1 mL
    XEROPHYLLUM ASPHODELOIDES (UNII: 9I4XB1GP2B) (XEROPHYLLUM ASPHODELOIDES - UNII:9I4XB1GP2B) XEROPHYLLUM ASPHODELOIDES15 [hp_X]  in 1 mL
    USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS15 [hp_X]  in 1 mL
    PARTHENIUM HYSTEROPHORUS (UNII: 151F45R21P) (PARTHENIUM HYSTEROPHORUS - UNII:151F45R21P) PARTHENIUM HYSTEROPHORUS16 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE15 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
    POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0) (POPULUS TREMULOIDES LEAF - UNII:7IIH57D9E0) POPULUS TREMULOIDES LEAF15 [hp_X]  in 1 mL
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G) (ROSA X DAMASCENA FLOWERING TOP - UNII:21W82Q764G) ROSA X DAMASCENA FLOWERING TOP15 [hp_X]  in 1 mL
    SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3) SALIX NIGRA BARK15 [hp_X]  in 1 mL
    ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W) ELYMUS REPENS ROOT15 [hp_X]  in 1 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM15 [hp_X]  in 1 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS15 [hp_X]  in 1 mL
    WYETHIA HELENIOIDES ROOT (UNII: J10PD1AQ0N) (WYETHIA HELENIOIDES ROOT - UNII:J10PD1AQ0N) WYETHIA HELENIOIDES ROOT15 [hp_X]  in 1 mL
    QUERCUS ROBUR NUT (UNII: Q7MU1F4GLY) (QUERCUS ROBUR NUT - UNII:Q7MU1F4GLY) QUERCUS ROBUR NUT15 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE6 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
    ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA15 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION15 [hp_X]  in 1 mL
    AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA15 [hp_X]  in 1 mL
    AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CARBONATE15 [hp_X]  in 1 mL
    ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU) ARALIA RACEMOSA ROOT15 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) (ARTEMISIA VULGARIS ROOT - UNII:32MP823R8S) ARTEMISIA VULGARIS ROOT15 [hp_X]  in 1 mL
    ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC) ARUNDO PLINIANA ROOT15 [hp_X]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS15 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK15 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
    CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV) (CALLUNA VULGARIS FLOWERING TOP - UNII:D9PC510CQV) CALLUNA VULGARIS FLOWERING TOP15 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS15 [hp_X]  in 1 mL
    DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (DYSPHANIA AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES15 [hp_X]  in 1 mL
    HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE15 [hp_X]  in 1 mL
    DROSERA ANGLICA (UNII: J61BY05EGY) (DROSERA ANGLICA - UNII:J61BY05EGY) DROSERA ANGLICA15 [hp_X]  in 1 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP15 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 mL
    FAGUS SYLVATICA NUT (UNII: I57ERU2601) (FAGUS SYLVATICA NUT - UNII:I57ERU2601) FAGUS SYLVATICA NUT15 [hp_X]  in 1 mL
    FRAXINUS AMERICANA BARK (UNII: 0B24UR1O1S) (FRAXINUS AMERICANA BARK - UNII:0B24UR1O1S) FRAXINUS AMERICANA BARK15 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE15 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE15 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2562-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/18/2020
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2562)
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